Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes—Protocol 3 with high dose)

Purpose

To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥250 μm on time-domain optical coherence tomography.

Design

Randomized, controlled, multicenter clinical trial.

Methods

Eligible eyes were randomized in a 1:1 ratio to 0.5 mg (n=77) or 2.0 mg (n=75) RBZ. Study eyes received 6-monthly injections.

Main outcome measures

The primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline.

Results

In all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P=0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P=0.708).

Conclusions

There was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.     

Two-year results of intravitreal ranibizumab for polypoidal choroidal vasculopathy with recurrent or residual exudation

Aim

To clarify the 2-year efficacy of ranibizumab for patients with polypoidal choroidal vasculopathy (PCV) with recurrent or residual exudation from branching vascular networks after previous photodynamic therapy (PDT).

Methods

We retrospectively reviewed 26 eyes of 26 Japanese patients (22 men, 4 women) in this pilot study. All eyes had PCV with complete regression of polypoidal lesions resulting from PDT detected by indocyanine green angiography (ICGA), but recurrent or residual leakage from branching vascular networks on fluorescein angiography and evidence of persistent fluid on optical coherence tomography (OCT). Three consecutive intravitreal injections of ranibizumab (0.5 mg/0.05 ml) were administered to all eyes.

Results

The mean logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA) improved significantly from 0.55 at baseline to 0.35 at 12 months (P<0.0001) and 0.43 at 24 months (P=0.0012). The mean increases in the BCVA 12 and 24 months after baseline were 1.95 and 1.23 lines, respectively. The mean central retinal thickness significantly decreased from 295 μm at baseline to 189 μm at 12 months (P<0.0038) and 163 μm at 24 months (P<0.001). The mean numbers of intravitreal ranibizumab (IVR) injections at months 12 and 24, including the initial treatments, were 5.8 and 8.8, respectively. Five (19.2%) eyes had recurrent polypoidal lesions on ICGA at a mean of 15.7 months after baseline. At month 24, OCT showed no exudation in 17 (65.4%) of the 26 eyes. No adverse events developed.

Conclusions

IVR injections maintained or improved the VA and retinal thickness at 24 months in eyes with PCV with recurrent or residual exudation from branching vascular networks after previous PDT.     

Intravitreal bevacizumab and ranibizumab injections for patients with polypoidal choroidal vasculopathy

Purpose

To compare the effectiveness of intravitreal injection of bevacizumab and ranibizumab in patients with treatment-naïve polypoidal choroidal vasculopathy (PCV).

Methods

A total of 66 and 60 eyes of 121 consecutive patients who received intravitreal bevacizumab (1.25 mg) or ranibizumab (0.5 mg) injection for treatment of PCV were retrospectively reviewed. After initial three loading injections by month, injection was performed as needed. Main outcome measures included best corrected visual acuity (BCVA), foveal center thickness (FCT) as assessed by spectral domain optical coherence tomography (SD-OCT), and change in polypoidal lesion on indocyanine green angiography (ICGA).

Results

At 12 months, average number of injections was 4.72±1.84 in the bevacizumab group and 5.52±1.54 in the ranibizumab group. Mean logarithm of the minimum angle of resolution of BCVA from baseline at 12 months after injection improved by 0.11 in the bevacizumab group (P=0.02) and by 0.14 in the ranibizumab group (P=0.01). Average FCT decreased from 368±62.48 to 298±40.77 μm in the bevacizumab group (P=0.01) and from 371±50.79 to 286±36.93 μm in the ranibizumab group (P=0.01). Polyp regression rate was 24.2% (16 eyes out of 66 eyes) in the bevacizumab group and 23.3% (14 eyes out of 60 eyes) in the ranibizumab group. There was no statistically significant difference in BCVA improvement achieved, FCT improvement achieved, and polyp regression rate between groups.

Conclusion

Intravitreal injections of bevacizumab and ranibizumab have similar effects in stabilization of visual acuity, macular edema, and regression of polypoidal complex with PCV eyes.     

Intravitreal ranibizumab for the treatment of choroidal neovascularisation secondary to angioid streaks

Aims

To assess the medium to long-term efficacy and safety of intravitreal ranibizumab for the treatment of choroidal neovascularisation (CNV) secondary to angioid streaks (AS).

Methods

A total of 12 eyes of nine patients treated with intravitreal ranibizumab (0.5 mg in 0.05 ml) for CNV secondary to AS were retrospectively identified. Efficacy of treatment was determined by changes in best-corrected LogMAR visual acuity (BCVA) and optical coherence tomography. Changes with respect to baseline BCVA were defined as improved or reduced with a gain or loss of more than 10 letters, respectively, or stable if remaining within 10 letters.

Results

Over a mean follow-up of 21.75 months (range: 1–54), patients received mean 5.75 (range: 2–15) intravitreal ranibizumab injections per affected eye. BCVA improved in three eyes (25%), stabilised in eight eyes (66.67%), and deteriorated in one eye (8.33%). There was no significant change in central retinal thickness (CRT) over the follow-up period (P=0.1072). No drug-related systemic side effects were recorded.

Conclusion

The long-term treatment of CNV secondary to AS with intravitreal ranibizumab showed a stabilisation in CRT and an improvement or stabilisation of BCVA. The absence of systemic side effects was reassuring. Further long-term prospective studies are required to validate these findings.     

Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12-month results

Purpose

To describe the efficacy of intravitreal aflibercept on 12-month visual and anatomical outcomes in patients with neovascular age-related macular degeneration (AMD) recalcitrant to prior monthly intravitreal bevacizumab or ranibizumab.

Methods

Non-comparative case series of 21 eyes of 21 AMD patients with evidence of persistent exudation (intraretinal fluid/cysts, or subretinal fluid (SRF), or both) on spectral domain OCT despite ≥6 prior intravitreal 0.5 mg ranibizumab or 1.25 mg bevacizumab (mean 29.8±17.1 injections) over 31.6±17.4 months who were transitioned to aflibercept.

Results

At baseline, best-corrected visual acuity (BCVA) was 0.42±0.28 logarithm of minimum-angle of resolution (logMAR), central foveal thickness (CFT) was 329.38±102.67 μm and macular volume (MV) was 7.71±1.32 mm³. After 12 months of aflibercept (mean 10.2±1.2 injections), BCVA was 0.40±0.28 logMAR (P=0.5), CFT decreased to 292.71±91.35 μm (P=0.038) and MV improved to 7.33±1.27 mm³ (P=0.003). In a subset of 15 eyes with a persistent fibrovascular or serous pigment epithelial detachment (PED), mean baseline PED greatest basal diameter (GBD) was 2350.9±1067.6 μm and mean maximal height (MH) was 288.7±175.9 μm. At 12 months, GBD improved to 1896.3±782.3 μm (P=0.028), while MH decreased to 248.27±146.2 μm (P=0.002).

Conclusion

In patients with recalcitrant AMD, aflibercept led to anatomic improvement at 12 months, reduction in proportion of eyes with SRF and reduction in PED, while preserving visual acuity.     

Association of retinal vessel calibre and visual outcome in eyes with diabetic macular oedema treated with ranibizumab

Purpose

The study aims to identify the association between the baseline retinal vascular calibre and visual outcome of patients with diabetic macular oedema (DMO) treated with intravitreal ranibizumab.

Methods

The 1-M field (as defined in the ETDRS study) of the digital colour fundus photographs of DMO patients who had been treated primarily with ranibizumab in a clinical trial was assessed. Of the 84 patients, 25 had gradable retinal photographs that could be subjected to analyses by the Interactive Vessel Analysis (IVAN) software at baseline. The average retinal vascular calibre of the six largest venules (CRVE) and the six largest arterioles (CRAE) in the peripapillary area (0.5 and 1 disc diameter from the optic disc margin) was measured. The relationship between CRVE and CRAE at baseline and the change in visual acuity at month 12 was assessed using the Mann–Whitney U test.

Results

Ten eyes from 10 patients who had shown an improvement of ≥2 lines of best corrected visual acuity (BCVA) at month 12 had a wider baseline CRVE (248.3±24.5 μm) compared with the 15 eyes from 15 patients who did not show the improvement of ≥2 lines (226.6±44.8 μm, P<0.05). The baseline CRAE did not differ significantly in these patients (156.1±22.7 vs 142±17.5 μm, P=0.17).

Conclusions

A wider baseline retinal venular calibre may be a predictor of better visual outcome in DMO eyes treated with ranibizumab. Further prospective studies with a larger sample size and a broader range of disease severity and visual acuity are needed to confirm this finding.     

Factors affecting visual outcomes in patients with diabetic macular edema treated with ranibizumab

Purpose

To identify factors associated with visual outcomes in patients with diabetic macular edema (DME) treated with ranibizumab (RBZ) in the Ranibizumab for Edema of the mAcula in Diabetes—Protocol 2 (READ-2) Study.

Patients and methods

Optical coherence tomography scans, fundus photographs, and fluorescein angiograms (FAs) were graded and along with baseline characteristics were correlated with month (M) 24 visual outcome of best-corrected visual acuity (BCVA) ≤20/100 (poor outcome) vs >20/100 (better outcome).

Results

Of 101 patients with a M20 visit or beyond, 27 (27%) had BCVA ≤20/100. Comparison of patients with or without poor outcome showed mean baseline BCVA of 16.8 letters (20/125) in the former compared with 30.4 letters (20/63; P<0.001). Mean change in BCVA between baseline and M24 was −2.6 letters in the poor outcome group compared with +9.8 letters (P<0.001). Foveal thickness (FTH) at M24 was 374.1 μm in the poor outcome group compared with 268.8 μm (P<0.01), a difference driven by 14 patients with mean FTH of 450.3 μm. Foveal atrophy occurred in 65% (11/17) in the poor outcome group compared with 17%(12/71, P=0.001). Persistent edema was noted in 52% (14/27) of patients with poor outcome. Laser scars near foveal center were significantly more common in patients with poor outcome who did not have edema vs those who did (78% (7/9) vs 23% (3/13) P=0.03).

Conclusion

Poor baseline BCVA (≤20/125) in DME patients predicts poor visual outcome (≤20/100) after 2 years of treatment with RBZ and/or focal/grid laser, often due to foveal atrophy and/or persistent edema.     

Ranibizumab for the treatment of choroidal neovascularisation secondary to pathological myopia: interim analysis of the REPAIR study

Aims

To evaluate the efficacy and safety of intravitreal ranibizumab in patients with choroidal neovascularisation secondary to pathological myopia (myopic CNV). Data are from a pre-planned, 6-month interim analysis.

Methods

Phase II, open-label, single arm, multicentre, 12-month study, recruiting patients (aged ≥18 years) with active primary or recurrent subfoveal or juxtafoveal myopic CNV, with a best-corrected visual acuity (BCVA) score of 24–78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye and a diagnosis of high myopia of at least −6 dioptres.Patients received 0.5 mg ranibizumab administered intravitreally to the study eye, followed by monthly injections given as needed (based on a predefined algorithm) for up to 11 months.

Results

At 6 months, mean BCVA improved from baseline by 12.2 letters, as did central macular thickness (in this interim analysis defined as a measure of either central subfield macular thickness or centre point macular thickness) from baseline by 108 μm in the 48 study eyes of 48 patients. Fewer patients had centre-involving intraretinal oedema (13.0% vs 91.5%), intraretinal cysts (10.9% vs 57.4%), or subretinal fluid (13.0% vs 66.0%) at 6 months than at baseline. Patients received a mean of 1.9 retreatments, were satisfied with ranibizumab treatment, and well being was maintained. No new safety signals were identified.

Conclusions

Results from the planned interim analysis support the role of ranibizumab in the treatment of myopic CNV, with excellent efficacy achieved with a low number of injections and few serious adverse events.     

Pilot study to evaLuate the role of high-dose rAnibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with perSistent/recurrenT macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study)

Purpose

To determine the efficacy of intravitreal ranibizumab 2.0 mg in patients with recalcitrant neovascular age-related macular degeneration (AMD).

Methods

This single-masked, randomized, prospective, pilot study enrolled patients with subfoveal neovascular AMD. All study eyes had persistent subretinal (SRF) or intraretinal fluid (IRF) on spectral-domain optical coherence tomography (SD-OCT) <30 days following at least 6 monthly intravitreal injections of ranibizumab or bevacizumab. Patients were randomized 2 : 1 to receive either ranibizumab 2.0 or 0.5 mg. Following three-loading treatments 4-weeks apart, both groups were treated using a ‘treat and extend'' regimen guided by eye-tracked SD-OCT through month 12. The primary end point was the mean change in best-corrected visual acuity (BCVA) at month 6.

Results

Nine eyes of 9 patients (mean age±SD, 82.0±5.8 years) were enrolled. Seven eyes received ranibizumab 2.0 mg and two eyes received 0.5 mg. Owing to the small number of patients enrolled, no statistical comparison could be made between the two dosages. At month 6, the mean improvement in BCVA was +6.1±3.7 (W=0, P<0.001) ETDRS letters and +2.0 ETDRS letters in the 2.0 and 0.5 mg groups, respectively. In the 2.0 mg group, there was a statistically significant decline in central foveal thickness, SRF and maximum pigment epithelial detachment height at 6 months compared with baseline. No adverse events were reported in either group.

Conclusion

Ranibizumab 2.0 mg has the potential to maintain or improve BCVA in some patients with persistent or recurrent SRF or IRF secondary to neovascular AMD despite prior monthly intravitreal anti-vascular endothelial growth factor therapy with the standard dose.     

Outcome of ranibizumab treatment in neovascular age related macula degeneration in eyes with baseline visual acuity better than 6/12

Background

The beneficial effect of intravitreal ranibizumab in the treatment of neovascular age-related macula degeneration (nAMD) is well known. Outcome data for eyes presenting with visual acuity better than 6/12 is limited.

Aims

To assess the effect of baseline vision on outcome in ranibizumab-treated nAMD eyes, including a subgroup with baseline vision ≥6/12 (<0.30 logmar).

Design

Prospective, consecutive and interventional case series.

Methods

A consecutive cohort of patients treated with intravitreal ranibizumab for nAMD with 52-week follow-up were studied. Patients who had received previous treatment for nAMD were excluded. Eyes were stratified according to baseline logmar visual acuity into four groups: <0.30 (>6/12), 0.30–0.59 (6/12–6/24), 0.60–0.99 (6/24–6/60) and 1.00–1.20 (6/60–6/96). Intravitreal ranibizumab (0.5 mg in 0.05 ml) was administered in three loading monthly doses followed by PRN dosing according to optical coherence tomography (OCT) findings.

Results

A total of 615 eyes were studied including 88 eyes with baseline vision <0.30. The mean change in logmar letters at 52 weeks was +5.5 (entire study group), −0.5 (<0.30 subgroup), +2.2 (0.30–0.59 subgroup), +6.5 (0.60–0.99 subgroup) and +15.3 (1.00–1.20 subgroup). In the <0.30 subgroup, 60 of 88 eyes (68%) had best-corrected visual acuity (BCVA) equal to or better than baseline and 82 of 88 eyes (93%) lost <15 letters at 52 weeks. Within this subgroup 56 of 67 eyes (84%) maintained UK driving standard BCVA visual acuity over the study period.

Conclusions

This study provides evidence that intravitreal ranibizumab treatment stabilises good vision in nAMD presenting with vision better than 6/12 over 52 weeks follow-up.     

Aflibercept Treatment for Neovascular Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy Refractory to Anti-vascular Endothelial Growth Factor

Purpose

To report the results of switching treatment to vascular endothelial growth factor (VEGF) Trap-Eye (aflibercept) in neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV) refractory to anti-VEGF (ranibizumab and bevacizumab).

Methods

This is a retrospective study involving 32 eyes from 29 patients; 18 were cases of neovascular AMD and 14 were cases of PCV. The best-corrected visual acuity (BCVA) and central macular thickness (CMT) of spectral-domain optical coherence tomography were evaluated.

Results

BCVA and CMT improved from 0.58 to 0.55 (p = 0.005) and from 404 to 321 µm (p < 0.001), respectively, after switching to aflibercept. The 14 eyes that received 6 or more aflibercept injections remained stable at 0.81 to 0.81 and 321 to 327 µm (p = 1.0, 0.29), respectively, after 3 aflibercept injections. The 10 eyes that received 3 or more bevacizumab injections after 3 or more aflibercept injections worsened, from 0.44 to 0.47 and from 332 to 346 µm (p = 0.06, 0.05), respectively. The results showed similar improvement of BCVA and CMT in neovascular AMD and PCV.

Conclusions

Aflibercept seems to be effective for improvement and maintenance of BCVA and CMT for neovascular AMD and PCV refractory to anti-VEGF. Switching from aflibercept back to bevacizumab treatment may not be a proper strategy.     

Intravitreal Anti-vascular Endothelial Growth Factor versus Observation in Acute Central Serous Chorioretinopathy: One-year Results

Purpose

To evaluate the efficacy of anti-vascular endothelial growth factor (VEGF) compared with observation for treating acute central serous chorioretinopathy (CSC).

Methods

A retrospective study of 36 patients with acute CSC, including 21 patients treated with anti-VEGF (anti-VEGF group) and 15 patients with observation (observation group). Patients in the anti-VEGF group received a single dose of bevacizumab or ranibizumab at baseline. Best-corrected visual acuity (BCVA), central foveal thickness (CFT) and resolution of subretinal fluid (SRF) on optical coherence tomography (OCT) were assessed. The integrity of the foveal inner segment/outer segment (IS/OS) line at 12 months was also analyzed.

Results

Resolution of SRF was achieved in 20 of 21 eyes in the anti-VEGF group and in 12 of 15 eyes in the observation group (p = 0.151). Mean BCVA and CFT were not different between the two groups at 12 months (p > 0.05). The amount of change in BCVA, however, differed significantly between the groups (p = 0.044). Final OCT more frequently detected the foveal IS/OS line in the anti-VEGF group than in the observation group (p = 0.012).

Conclusions

In terms of BCVA, anti-VEGF and observation only had similar therapeutic effects in acute CSC patients. In some patients, however, the rapid resolution of SRF by anti-VEGF might reduce the risk of photoreceptor degeneration and improve long-term visual acuity.     

Efficacy of subthreshold micropulse laser in the treatment of diabetic macular edema is influenced by pre-treatment central foveal thickness

Purpose

To determine if the severity of diabetic macular edema influences the effectiveness of subthreshold micropulse (STMP) laser treatment.

Methods

A total of 63 eyes of 58 patients with diabetic macular edema were divided into two groups based on their initial central foveal thickness (CFT). Group 1 had CFT ≤400 μm, group 2 had CFT >400 μm. The change from baseline in CFT and visual acuity were compared at 3, 6 and 12 months follow-up. Patients were considered for retreatment with micropulse laser at 3 months if macular edema had not improved. Patients were considered for rescue anti-VEGF injections if there was clinically significant macular edema at 6 months follow-up. Number of laser retreatments, injections, and any adverse effects from STMP laser were recorded.

Results

Group 1 (n=33) experienced an average of 55 μm reduction in CFT and 0.2log MAR gain in visual acuity at 12 months (P<0.001). No patient required rescue anti-VEGF injections. Group 2 (n=30) experienced no significant change in CFT or visual acuity by 6 months despite retreatment with STMP in 19 eyes. From 6 to 12 months follow-up, all the patients in group 2 received rescue Bevacizumab injections that resulted in 307 μm reduction in CFT and 0.3log MAR improvement in visual acuity (P<0.001). No adverse effects from STMP laser were recorded.

Conclusion

Severity of edema can influence the effects of STMP laser. STMP monotherapy is safe and effective in treating edema of mild to moderate severity.     

Residual edema evaluation with ranibizumab 0.5?mg and 2.0?mg formulations for diabetic macular edema (REEF study)

Purpose

To compare the efficacy of ranibizumab 0.5-mg and 2.0-mg intravitreal injections for persistent diabetic macular edema (DME) previously treated with bevacizumab.

Methods

In all, 43 patients with residual center-involved DME following intravitreal bevacizumab were included in this 12-month prospective, nonrandomized, multicenter study. Enrolled patients received three monthly ranibizumab 0.5-mg injections. At month 3, patients with residual macular edema switched to three monthly injections of ranibizumab 2.0-mg. Assessments included monthly visual acuity and spectral-domain optical coherence tomography.

Results

Mean visual acuity improved by +6.4 letters at month 3 and +8.8 letters at month 6. Mean central subfield thickness (CST) decreased by –113 μm at month 3 and –165 μm at month 6. Before enrollment, 29/43 (67.4%) patients showed <10% CST reduction following monthly bevacizumab treatment. After three monthly ranibizumab 0.5-mg injections, 22/29 (75.9%) patients showed >10% reduction in CST, whereas 6 showed <10% reduction. Of these six, three (50%) showed >10% reduction in CST after switching to three monthly ranibizumab 2.0-mg doses. No serious adverse events were observed to month 6.

Conclusion

Ranibizumab 0.5-mg or 2.0-mg may improve visual and anatomic outcomes in patients with DME who demonstrated minimal or no response to bevacizumab therapy. Moreover, increased dosage of ranibizumab (2.0-mg) may provide additional benefit over ranibizumab 0.5-mg in some patients. However, 2.0-mg ranibizumab is not currently commercially licensed or available.     

Short-term effectiveness of intravitreal bevacizumab vs. ranibizumab injections for patients with polypoidal choroidal vasculopathy

Purpose

To compare the effectiveness of intravitreal injections of bevacizumab and ranibizumab in patients with treatment-naive polypoidal choroidal vasculopathy (PCV).

Methods

Records from 106 consecutive patients who received intraviteral bevacizumab (n = 58, 1.25 mg) or ranibizumab (n = 52, 0.5 mg) for treatment of PCV were retrospectively reviewed. After three initial monthly loading injections, injection was performed as needed. The main outcome measures included best-corrected visual acuity (BCVA), foveal central thickness (FCT) as assessed by spectral domain optical coherence tomography, and the changes in polypoidal lesions based on an indocyanine green angiography.

Results

The average number of injections was 3.31 ± 1.25 in the bevacizumab group and 3.44 ± 0.92 in the ranibizumab group. Mean logarithm of the minimum angle of resolution of BCVA from baseline to 6 months after injection improved by 0.17 in the bevacizumab group (p = 0.03) and by 0.19 in the ranibizumab group (p = 0.01). Average FCT decreased from 322 ± 62.48 µm to 274 ± 40.77 µm in the bevacizumab group (p = 0.02) and from 338 ± 50.79 µm to 286 ± 36.93 µm in the ranibizumab group (p = 0.02). Polyp regression rate was 20.7% (12 of 58 eyes) in the bevacizumab group and 21.2% (11 of 52 eyes) in the ranibizumab group. There was no statistically significant difference between groups in BCVA improvement achieved, FCT improvement achieved, and polyp regression rate between groups.

Conclusions

Intravitreal injections of bevacizumab and ranibizumab have similar effects in stabilizing of visual acuity, macular edema, and regression of polypoidal complex in PCV eyes over the short term.     

Prevalence and incidence of blindness and other degrees of sight impairment in patients treated for neovascular age-related macular degeneration in a well-defined region of the United Kingdom

Aims

This study aimed to evaluate the incidence and prevalence of blindness, sight impairment, and other visual acuity (VA) states in patients receiving ranibizumab for neovascular age-related macular degeneration (nAMD) in Gloucestershire.

Methods

Serial VA and injection data for all treatment-naive patients receiving their first intravitreal injections of ranibizumab for nAMD in the Gloucestershire National Health Service Ophthalmology department between 2008 and 2010 were extracted from an electronic medical record system.

Results

The prevalence of blindness (VA in the better-seeing eye ≤25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters) at the time of first intravitreal injection was 0.8%, increasing to 3.5% after 3 years. The prevalence of sight impairment (VA in the better-seeing eye 26–39 ETDRS letters) increased from 4.1% at baseline to 5.5% after 3 years. The incidence of initiating ranibizumab treatment for nAMD in people aged ≥50 years in Gloucestershire was 111 people per 100 000 population in 2009, and 97 people in 2010. The incidence of patients meeting the visual criteria for blindness and sight impairment registration from treated nAMD in people aged ≥50 years in Gloucestershire was 3.5 and 9.7 people, respectively per 100 000 population in 2010.

Conclusion

This is the first real-world study on the incidence and prevalence of eligibility for blindness and sight impairment registration in treated nAMD in the UK based on VA data. The incidence and prevalence of eligibility for certification of blindness or sight impairment in patients treated with ranibizumab for nAMD is low in Gloucestershire, with only 3.6% of the incident population progressing to blindness in 2010.     

Evaluating the impact of summer vacation on the visual acuity of AMD patients treated with ranibizumab

Purpose

To evaluate the impact of traditional French summer vacation on visual acuity and spectral domain-optical coherence tomography (SD-OCT) of Wet AMD patients being treated with intravitreal Ranibizumab.

Methods

This was a consecutive, comparative, single-centre, prospective analysis. All patients who were being treated with intravitreal injection of 0.5 mg ranibizumab at Cergy Pontoise Hospital, Department of Ophthalmology between July 2013 and September 2014 were included. Patients were divided into two groups: (A) patients who skipped one ranibizumab intravitreal injection during holidays, and (B) patients who received injection during their holidays. Evaluations occurred prior to traditional holiday (baseline) and 2 months later, consisting of BCVA using ETDRS, and a complete ophthalmic examination that included slit-lamp biomicroscopy, fundus examination, fluorescein angiography (FA), indocyanine green angiography (ICGA), and spectral domain-optical coherence tomography (SD-OCT). All patients were being treated with PRN anti-VEGF regimen and criteria for reinjection included a visual acuity loss >5 ETDRS letters and/or an increase of central retinal thickness, presence of subretinal fluid, intraretinal fluid, or pigment epithelium detachment. If reinjection criteria were not met, patients were advised to return in 4 weeks.

Results

The mean visual acuity change was −0.071±0.149 (LogMAR) in group A and +0.003±0.178 in group B (P=0.041). At the second visit (2 months after preholidays visit), 61.8% of patients in group A had SRF and/or intraretinal cysts, and only 27.6% of patients in group B. There was a significant difference in the persistence of fluid between the two groups (P=0.007, χ²-test).

Conclusion

This cases series demonstrated the detrimental impact of holidays on visual acuity in patients treated with ranibizumab for AMD, which, in spite of their treatment regimen, still leave in vacation. Therefore, it is important to convey the message of treatment adherence to patients, despite their need of holidays.     

Effect of a single intravitreal bevacizumab injection on different optical coherence tomographic patterns of diabetic macular oedema

Purpose

The aim of this study is to compare the therapeutic effect of a single intravitreal bevacizumab (IVB) injection in eyes with diabetic macular oedema (DMO) of different patterns determined by optical coherence tomography (OCT).

Methods

Medical records of patients who had a single IVB injection for DMO were analysed retrospectively. Eyes with a clinically significant DMO and a central foveal thickness (CFT) of 250 μm or more determined by OCT were included in the analysis. Best-corrected visual acuity (BCVA), CFT and total macular volume values before and after the injection were recorded. Eyes were divided into sponge-like diffuse retinal thickening (DRT), cystoid macular oedema (CMO) and serous retinal detachment (SRD) groups according to the morphology on OCT.

Results

A total of 92 eyes (42 with DRT, 31 with CMO and 19 with SRD) were included in the study. There was no statistically significant variation between three groups regarding the change in BCVA (P=0.695). CMO and SRD groups had greater reductions in their mean CFT, and the amount of reduction showed statistically significant variation between three groups (P=0.048). However, no statistically significant difference was found between groups in terms of percentage of change in CFT (P=0.278).

Conclusion

CMO and SRD subtypes are associated with a greater reduction in the CFT than the DRT subtype. Although the change in BCVA was not significantly different between groups, the DRT group showed markedly better visual improvement in proportion to the decrease in CFT.     

Twelve-month experience with Ozurdex for the treatment of macular edema associated with retinal vein occlusion

Purpose

To evaluate the efficacy and safety of a dexamethasone implant (Ozurdex) alone or in combination with bevacizumab.

Methods

Sixty-four eyes were prospectively investigated. Group 1 (22 central retinal vein occlusion (CRVO) and 16 branch retinal vein occlusion (BRVO)) was treated with Ozurdex alone, and group 2 (14 CRVO and 12 BRVO) was treated with three consecutive bevacizumab injections followed by Ozurdex. Recurrences were treated with Ozurdex only. Patients were seen preoperatively and thereafter in monthly intervals. The primary end point was best-corrected visual acuity (BCVA) at 12 months.

Results

In group 1, BCVA improved by 6.6 (±1.7) letters in CRVO and 7.8 (±2.9) in BRVO patients, and in group 2 by 9.8 (±1.0) vs 9.4 (±2.1) letters. A significant difference was only seen between CRVO patients in group 1 and 2 at 12 months (P<0.05). Recurrence after the first Ozurdex injection occurred after 3.8 (CRVO) and 3.5 months (BRVO) in group 1, vs 3.2 and 3.7 months in group 2. Elevated intraocular pressure (>5 mm Hg) was measured in approximately 40% cataract progression requiring surgery in about 50% of eyes after three Ozurdex injections.

Conclusion

Combined treatment showed slightly better functional outcome for CRVO patients. Increased intraocular pressure and cataract progression was frequent and should be considered when an individual treatment is planned.     

Outcome of polypoidal choroidal vasculopathy at 1 year by combined therapy of photodynamic therapy with ranibizumab and predictive factors governing the outcome

Aim

To report the visual outcome of polypoidal choroidal vasculopathy receiving combined treatment with photodynamic therapy using Visudyne and intravitreal ranibizumab injections, and to analyze the predictive factors of visual outcome at 1 year post treatment.

Methods

Seventy-four consecutive patients with newly diagnosed polypoidal choroidal vasculopathy were treated with photodynamic therapy using Visudyne and three loading doses of intravitreal ranibizumab. The final visual outcome and polyp eradication rate at 1 year were reported. A stepwise regression model was used to estimate the baseline clinical factors predictive of better visual outcome and polyp eradication.

Results

Visual acuities at 12-months follow-up improved significantly compared with baseline from 0.828 logMAR to 0.728 logMAR (P=0.026). The mean foveal thickness decreased from 380±175 to 278±117 μm. In all 29.7% of eyes improved at least by 0.3 logMAR, and 55.4% remained stable in visual acuity with less than 0.3 logMAR change. Overall, 85% of eyes achieved at least stable vision, 20.2% (15/74) cases achieved polyp eradication on angiogram, and 60.8% (45/74) achieved polyp size reduction on angiogram at 1 year. Regarding predictive factors, the baseline visual acuity (P=0.003), no foveal involvement by abnormal choroidal vasculature (P<0.0001), absence of hard exudates (0.001) or subretinal fluid (<0.0001) are important clinical factors affecting the final visual outcome.

Conclusions

Combination therapy with photodynamic therapy using Visudyne and three loading doses of intravitreal ranibizumab injections resulted in 85% success rate on visual stabilization and 81% success rate in polypoidal lesion control.