Impact of treatment of diabetic macular edema on visual impairment in people with diabetes mellitus in India

Purpose:The aim of this study was to report visual and anatomical outcomes following treatment for diabetic macular edema (DME) in clinical practice in India.Methods:Retrospective chart review of patients with DME who were initiated on treatment and followed up for at least 1 year at 9 tertiary eye care centers during 2016–2017 was performed. Data on demographics, systemic illnesses, visual acuity and anatomical characteristics of DME, treatment history were collated and analyzed for change in visual acuity level and central macular thickness at 1 year.Results:A total 1853 patients were diagnosed with treatable DME during study period, 1315 patients were treated and 556 patients (1019 eyes) followed up at one year. Although patients achieved significantly better anatomical outcome (central macular thickness of <300μ in 32.3% at baseline compared to 60.7% at 1 year, P < 0.001), visual impairment due to DME did not differ from baseline (mild visual impairment in 53.2% at baseline compared to 56% at 1 year, P = 0.7). Cystoid type of DME was the most common phenotype (432/1019, 42.4%) followed by spongy type (325, 31.9%) and cystoid plus spongy type (138, 13.5%). Bevacizumab monotherapy was the most common (388/1019, 38.1%) treatment followed by combination therapy (359, 35.2%). Mean number of anti-VEGF injections received per eye in a year was 2.1 (SD ± 0.9).Conclusion:Only about a third of treated DME patients complete one year follow up in India. Most patients receive suboptimal number of treatments. Treated DME cases largely show better anatomical outcome but not a better functional outcome.     

Intraocular cytokines in retinal vein occlusion and its relation to the efficiency of anti-vascular endothelial growth factor therapy

Purpose:To analyze the change in the concentration of intraocular cytokines (ICs) in patients with retinal vein occlusion (RVO) before and after intravitreal ranibizumab therapy (IVR), and to find the correlations of IC with clinical activity of RVO and efficiency of treatment.Results:The levels of 11 cytokines (vascular endothelial growth factor [VEGF], receptor antagonist interleukin-1, interleukin-6 [IL-6], IL-8, IL-9, IL-10, IL-12r70, IL-13, IL-15, monocyte chemotactic protein-1 [MCP-1], regulated on activation, normal T expressed and secreted) were significantly (P < 0.05) different compared to control and significantly (P < 0.05) changed after IVR both in central and branch RVO. The patients were divided into two groups: the first -“effective” and the second - “partially effective” therapy. The second group characterized by the higher concentrations of VEGF, IL-8, IL-10, IL-17, and MCP-1 at baseline compared to the first group.Conclusion:The patients with RVO were characterized by the increased levels of VEGF and other pro- and anti-inflammatory cytokines and chemokines. Aqueous concentration of cytokines were different in patients with central and branch RVO and significantly changed after IVR. Insufficient response to IVR was associated with activation of immune-inflammatory processes.     

Change of retinal pigment epithelial atrophy after anti-vascular endothelial growth factor treatment in exudative age-related macular degeneration

Purpose:The study aimed to investigate the quantitative changes of retinal pigment epithelial (RPE) atrophy during a 24-month follow-up period of anti-vascular endothelial growth factor (VEGF) for exudative age-related macular degeneration (AMD).Results:The mean number of anti-VEGF treatments was 9.18. RPE atrophic area was 1.293 ± 1.298 mm² at baseline and enlarged to 2.394 ± 1.940 mm² after 24 months, which differed significantly (P = 0.001). Multiple regression analysis revealed that larger areas of RPE atrophy at month 4 and larger numbers of anti-VEGF treatments were associated with increased RPE atrophic areas.Conclusions:RPE atrophy progresses in eyes with exudative AMD during anti-VEGF treatment. Larger areas of RPE atrophy at month 4 and larger numbers of anti-VEGF injections were associated with an increased risk of progression of RPE atrophy the following treatment. These findings may be useful to clinicians using intravitreal anti-VEGF for the treatment of exudative AMD, both for selecting an appropriate treatment plan and for predicting the progression of RPE atrophy.     

Spontaneous or secondary to intravitreal injections of anti-angiogenic agents retinal pigment epithelial tears in age-related macular degeneration

AIM:To evaluate the visual function evolution of retinal pigment epithelial (RPE) tears in patients with age-related macular degeneration (AMD) according to type of occurrence [spontaneous or secondary to anti-vascular endothelial growth factor (anti-VEGF) injection] and the topographic location of the tear after a two-year follow-up period.METHODS:A total of 15 eyes of 14 patients with RPE tears in exudative AMD were analyzed retrospectively at the University Eye Clinic of Trieste. Inclusion criteria were:patient age of 50 or older with AMD and RPE tears both spontaneous occurring or post anti-VEGF treatment. Screening included:careful medical history, complete ophthalmological examination, fluorescein angiography (FA), indocyanine green angiography (ICG), autofluorescence and infrared imaging and optical coherence tomography (OCT). Patients were evaluated every month for visual acuity (VA), fundus examination and OCT. Other data reported were:presence of PED, number of injections before the tear, location of the lesion.RESULTS: Mean follow-up was 24wk (SD±4wk). A total of 15 eyes were studied for RPE tear. In 6 cases (40%), the RPE tears occurred within two years of anti-VEGF injections the others occurred spontaneously. In 13 cases (86.6%), the RPE tear was associated with pigment epithelial detachment (PED). In 7 cases (46.6%), the RPE tear occurred in the central area of the retina and involved the fovea. Two lesions were found in the parafoveal region, six in the extra-macular area. In all cases visual acuity decreased at the end of the follow-up period (P<0.01) independently of the type or the topographical location of the lesion.CONCLUSION:RPE tear occurs in exudative AMD as a spontaneous complication or in relation to anti-VEGF injections. Visual acuity decreased significantly and gradually in the follow-up period in all cases. No correlation was found between visual loss and the type of onset or the topographic location of the tears.     

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab

Purpose:The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO).Methods:We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up.Results:One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted.Conclusion:Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases.     

Foveal Microvascular Integrity Association With Anti-VEGF Treatment Response for Diabetic Macular Edema

PurposeTo investigate the association between foveal microvascular integrity and anti-vascular endothelial growth factor (VEGF) treatment response for diabetic macular edema (DME).MethodsThis retrospective study enrolled 58 eyes (from 45 patients) with DME. Treatment strategy was three to five monthly anti-VEGF injections followed by a PRN protocol. Treatment with an intravitreal corticosteroid would be considered for persistent DME after five consecutive anti-VEGF injections. Eyes achieving a treatment-free interval ≥ four months within two years were classified into the good clinical course group (group 1). Eyes with frequent recurrent edema (treatment-free interval < four months) or requiring an intravitreal corticosteroid within two years were classified into the suboptimal clinical course group (group 2). Foveal microvascular integrity was evaluated by two continuous variables, that is, vessel density (%) within a width of 300 µm around the foveal avascular zone (FD-300) on optical coherence tomography angiography (OCTA) and perifoveal leakage (area %) on fluorescein angiography (FA).ResultsThere were 37 eyes in group 1 and 21 eyes in group 2. FD-300 (odds ratio 0.733, 95% CI 0.620–0.867, P < 0.001) and perifoveal leakage (odds ratio 1.064, 95% CI 1.007–1.124, P = 0.027) were significantly associated with suboptimal clinical course. Area under curve (AUC) was 0.820 for FD-300 and 0.723 for perifoveal leakage in predicting clinical course. FD-300 was negatively correlated with perifoveal leakage (coefficient = −0.325, P = 0.014).ConclusionsCompromised foveal microvascular integrity, represented by lower FD-300 and more severe perifoveal fluorescein leakage, was associated with suboptimal clinical course in anti-VEGF treatment for DME. A negative correlation between FD-300 and perifoveal leakage existed.     

Significance of monitoring vascular endothelial growth factor,monocyte chemoattractant protein-1 and Interleukin-8 in diabetic macular edema towards early identification of nonresponders to ranibizumab therapy

Purpose:Identification of nonresponders prior to anti-vascular endothelial growth factor (anti-VEGF) therapy would help in the judicious clinical management of diabetic macular edema (DME) patients. Thus, a systematic study was initiated to identify nonresponding DME patient population undergoing ranibizumab treatment to figure out additional inflammatory components that may contribute to their nonresponsiveness to anti-VEGF therapy.Methods:A total of 40 patients recruited to this investigator-initiated trial received intravitreal ranibizumab monthly for 3 months. The fourth- and fifth-month injections were according to PRN protocol and the sixth-month injection was mandatory. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and VEGF in aqueous humor were measured for all the patients. Patients were grouped into responders/nonresponders on the formulated criteria and the levels of key pro-inflammatory cytokines were also measured between the two groups at baseline, 2 month and 5 months using cytometric bead array (CBA).Results:Eleven patients were categorized (29.72%) as responders and 10 patients (27.02%) as nonresponders. Nonresponders showed poorer BCVA (P = 0.024, 0.045, and 0.048 for 4, 5, and 6 months) and higher CMT (P = 0.021, 0.0008 and <0.0001 for baseline, 1, 2, 3, 4, 5, and 6 months) compared to responders. The cytokines IL-8, MCP-1 were significantly up regulated (P = 0.0048 and 0.029 for MCP-1 and IL-8) in nonresponders.Conclusion:Elevated MCP-1 and IL-8 levels found in the nonresponders could be used as a prognostic marker to identify these groups of patients and can help in developing alternative treatment options along with anti-VEGF therapy.     

One-year outcomes of Aflibercept for refractory diabetic macular edema in Bevacizumab nonresponders

Purpose:A sub-population of patients with diabetic macular edema (DME) responds less effectively to off-label use of Bevacizumab. Approval of Aflibercept for DME has offered Bevacizumab nonresponders an alternative therapeutic option. Herein, we investigate the anatomical and functional changes associated with Aflibercept treatment in Bevacizumab nonresponders with chronic DME in a Canadian setting.Methods:A retrospective study of eyes with persistent DME that were switched to Aflibercept due to nonresponse following ≥6 consecutive monthly Bevacizumab injections was performed. Anatomical and functional changes and the predictors of response were assessed using patients'' characteristics prior to receiving their first (baseline) and seventh consecutive Aflibercept injections (follow-up).Results:Twenty-four eyes were included, with a mean age of 63.9 ± 10.7 years, an average of 16.8 ± 8.5 Bevacizumab injections prior to switching to Aflibercept, and mean follow-up duration of 11.8 ± 1.7 months following switching to Aflibercept. Best-corrected visual acuity (BCVA) improved significantly from 0.49 ± 0.13 to 0.41 ± 0.11 logMAR (P < 0.001) and central subfield thickness (CST) decreased by 119.4 μm from 409.4 ± 85.8 μm to 290.0 ± 64.5 μm (P < 0.001), with 50% of eyes showing complete anatomical response. Worse BCVA and higher CST at baseline predicted greater vision improvements (P = 0.001 and P = 0.035, respectively) while a larger decrease in CST was associated with greater baseline CST (P = 0.001) and better glycemic control (P = 0.039).Conclusion:Our data from a real-world clinical setting highlight the efficacy of Aflibercept as an alternative therapeutic option for DME recalcitrant to Bevacizumab, with potential additional benefit to those with worse vision, greater CST, and better glycemic control at baseline.     

Ozurdex for refractory macular edema secondary to diabetes,vein occlusion,uveitis and pseudophakia

ObjectiveTo analyze the functional and morphological effects of the intravitreal dexamethasone implant (Ozurdex, Allergan) on patients with macular edema secondary to retinal vein occlusion (RVO), diabetic retinopathy (DME), posterior noninfectious uveitis (NIU), or pseudophakic Irvine-Gass syndrome (IGS).Methods144 charts were retrospectively reviewed; 100 eyes met inclusion criteria for analysis: at least one intravitreal dexamethasone implant injection, refractory to antivascular endothelial growth factor, and had ≥6 months of follow-up postinsertion. The primary outcome was the efficacy of the dexamethasone implant in reducing macular edema as measured by reduction in central retinal thickness (CRT). Secondary outcomes included visual acuity (VA), duration of treatment efficacy (measured by time to next treatment), and safety. The Wilcoxon signed-rank test was used to compare values from baseline, and Kaplan-Meier survival curves were used to analyze time to retreatment.ResultsThere were 28 patients with RVO, 30 with DME, 24 with posterior NIU, and 18 with IGS. VA improved from baseline to month 6 in all groups, but was not statistically significant. CRT improved in all 4 groups, and was statistically significant for DME (p = 0.008) and NIU (p = 0.05). At 3 months, 34 patients (41.5%) required retreatment; by month 6, 46 patients (56.1%) required retreatment. There was a large variation between the groups in number of patients requiring intraocular pressure (IOP)–lowering medications. Two patients needed IOP-lowering surgery. One patient developed endophthalmitis.ConclusionThe use of intravitreal dexamethasone implants in patients with refractory retinal diseases is well tolerated and results in consistently improved anatomic outcomes, but the positive anatomic outcomes are not necessarily correlated to improvements in visual function. Patients who are treated earlier in the disease process will had better outcomes. This patient population were refractory to treatment and, therefore, have less-predictable functional outcomes.     

黄斑水肿的微视野评估与视力的相关性研究

目的：分析不同疾病引起的黄斑水肿患者微视野检查与视力的相关性。

方法：纳入黄斑水肿患者127例164眼,其中年龄相关性黄斑病变(ARMD)38例38眼,视网膜静脉阻塞(RVO)43例43眼,糖尿病性黄斑水肿(DME)46例83眼。所有患者均行最佳矫正视力(BCVA),光学相干断层扫描仪(OCT)及黄斑微视野检查,并进行统计学分析。

结果：黄斑水肿患者的总体视网膜平均敏感度(MS)、固视率(P1,P2)与BCVA呈正相关,而黄斑视网膜厚度(CRT)与BCVA呈负相关。ARMD组MS与BCVA呈正相关,而固视率及CRT与BCVA不相关; DME组和视网膜中央静脉阻塞(CRVO)组中MS及P1,P2与BCVA均呈正相关,DME组CRT与BCVA呈负相关,CRVO组CRT则与BCVA不相关; 视网膜分支静脉阻塞(BRVO)组MS和CRT与BCVA均不具相关性。

结论：微视野检查对ARMD患者的评估可能比OCT更能反映黄斑功能的变化,在CRVO及DME的患者中微视野作为主观评价指标与OCT有协同作用,而在BRVO患者中微视野的评价仍需进一步研究。     

Retrospective hospital-based analysis of age-related macular degeneration patterns in India: 5-year follow-up

Purpose:To provide a detailed analysis of age-related macular degeneration (AMD) with a 5-year follow-up at a Tertiary Eye Care Center in India.Methods:In this retrospective institutional study, 408 eyes of 204 subjects (100 males) with a diagnosis of AMD with minimum 5-year follow-up were included. Data collected included demographics, details of the ocular exam, special investigations performed, treatment offered, complications, and systemic diseases, if any.Results:The median age was 74.24 ± 8.23 years. Median follow-up was 5.77 years. The visual acuity (VA) at baseline and last visit was 0.74 ± 0.12 (Snellen''s equivalent 20/100) and 0.54 ± 0.12 logarithm of the minimum angle of resolution (Snellen''s equivalent 20/50; P = 0.032) in patients with choroidal neovascular membrane (CNVM). The most common complaint was decreased vision (94.5%). AMD (any stage) was found to be bilateral in 93% of patients at baseline and 197 patients (96.56%) at 5 years. Seventeen eyes had active CNVM (12 of these were occult) at presentation. At baseline, 43 eyes had a disciform scar. Three hundred twenty-one eyes had dry AMD at baseline (geographic atrophy - 12 [3.7%] eyes). Five-year conversion rate into wet AMD and geographic atrophy was 2.87% and 3.12%. Median number of anti-vascular endothelial growth factor injections administered per patient was 2.8 ± 1.2. CNVM bilaterality was low (7.5%).Conclusion:Patients with AMD in India presented later in the course of the disease. Bilateral advanced AMD and geographic atrophy were uncommon. Five-year conversion rate into wet AMD and geographic atrophy was 2.87% and 3.12%.     

False alarms and the positive predictive value of smartphone-based hyperacuity home monitoring for the progression of macular disease: a prospective cohort study

BackgroundHome monitoring of hyperacuity allows early detection of progression in exudative neovascular age-related macular degeneration (nvAMD) and diabetic macular oedema (DMO). However, false alarms may pose a significant burden to both patients and healthcare professionals alike.PurposeTo assess the false alarm rate and positive predictive value of smartphone-based home monitoring of nvAMD and DMO.MethodsPatients treated with anti-angiogenic therapy in a pro re nata scheme for nvAMD or DMO at the Medical Retina service (Lucerne, Switzerland) between March and June 2016 were included in this prospective cohort study. The home monitoring test Alleye (Oculocare Ltd, Switzerland) provided a session score from 0–100 in addition to a traffic-light system feedback via the smartphone application. Three consecutive “red” scores were considered as a positive test or alarm signal. Specificity, 1-specificity (false alarm rate) and the predictive value for optical coherence tomography-based disease progression were analysed.Results73 eyes of 56 patients performed 2258 tests in 222 “follow-up periods”. Progression was observed in 141 periods (63.5%). The specificity of the test was 93.8% (95% CI: 86.2–98.0%), the false alarm rate 6.1% (95% CI: 2.0–13.8%), and the positive predictive value 80.0% (95% CI: 59.3–93.2%) for the detection of progression.ConclusionFalse alarm rates for the detection of progression in macular disease via home monitoring is low. These findings suggest that home monitoring may be a useful adjunct for remote management of nvAMD and DMO.Subject terms: Diagnosis, Health services     

Profile of patients receiving intravitreal anti-vascular endothelial growth factor injections during COVID-19-related lockdown

Purpose:The aim of this study was to analyze the impact on vision due to delay in presentation of patients requiring intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections, consequent to COVID-19-related travel restrictions.Methods:Data were collected retrospectively of patients who received anti-VEGF injections during four months of the COVID-19 pandemic. Visual acuities, indication for treatment were noted along with basic demographic characteristics.Results:Data were analyzed for 303 eyes of 263 patients. The indication for treatment was age-related macular degeneration (AMD) in 60 eyes (19.8%), while 162 eyes (53.5%) had Diabetic Macular Edema, 71 eyes (23.4%) had Retinal Vein Occlusion and 10 eyes (3.3%) had other diagnosis. The visual acuity in the treatment naïve eyes (Group A, n = 168) was significantly worse (P < 0.001) than those who presented for retreatment (Group B, n = 135). In Group B, there was a significant decline in vision for the entire cohort (P = 0.009) and those with AMD (P = 0.036). Those in Group B presented at a mean interval of 19.1 ± 10.6 (range, 4–64) weeks for retreatment.Conclusion:The COVID-19 pandemic has led to a delay in patients receiving anti-VEGF injections. The visual acuity is worse in both treatment naïve as well as those requiring retreatment. This could have long-term impact on vision of patients requiring this vision preserving treatment.     

玻璃体内注射康柏西普对糖尿病黄斑水肿患者和继发于视网膜静脉阻塞的黄斑水肿患者的疗效差异

目的 探讨玻璃体内注射康柏西普对糖尿病黄斑水肿(DME)患者和继发于视网膜静脉阻塞(RVO)的黄斑水肿患者的疗效差异。方法 回顾性研究。选取2019年8月至2021年12月在苏州市立医院北区眼科行玻璃体内注射康柏西普治疗的DME患者44例63眼记为DME组,另选取采用同样方法进行治疗的继发于RVO的黄斑水肿患者40例40眼记为RVO组。采用国际标准视力表(小数)检查并记录患者最佳矫正视力(BCVA),采用德国海德堡公司OCT仪进行OCT检查,自动测量患者黄斑中心凹1 mm视网膜厚度并以此作为黄斑中心视网膜厚度(CMT)。所有患者玻璃体内均一次性注射0.05 mL康柏西普(成都康弘生物科技有限公司)。对比分析DME组和RVO组患眼基线特征及康柏西普治疗后7 d疗效差异。结果 DME组患眼基线CMT为(484.94±152.89)μm, RVO组为(582.33±241.57)μm, RVO组基线CMT高于DME组,差异有统计学意义(P<0.05)。DME组患眼基线BCVA为0.31±0.20,RVO组为0.29±0.23,差异无统计学意义(P>0.05)。注射后7 d, DM...     

Ten-year outcome of anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration

Purpose:The aim of this study was to report the 10-year visual outcome in eyes treated with anti-vascular endothelial growth factor (anti-VEGF) agents for neovascular age-related macular degeneration (nAMD) and to assess the impact of switching treatment as part of routine clinical care.Methods:Electronic records of treatment-naïve eyes initiated on intravitreal ranibizumab between January and December 2009 were accessed. The primary outcome measured was the change in visual acuity (VA) in Early Treatment of Diabetic Retinopathy Study letters. The frequency and reasons for treatment discontinuation during each year of follow-up and the impact of switching from ranibizumab to aflibercept were some of the secondary outcomes.Results:Of the 223 eyes (203 patients), 60 eyes completed 10 years of continuous follow-up. After a mean follow-up of 121.4 months, VA declined by 5.6 letters (95% confidence interval [CI] –0.25 to –11.1, P = 0.04). Final VA of ≥70 letters was seen in 20% of eyes and 35% had VA ≤ 35 letters. VA gain of ≥10 letters was seen in 23% and loss of ≥10 letters was seen in 40% of the eyes. Twenty-nine eyes remained on ranibizumab monotherapy and 31 switched to aflibercept. Switched eyes showed a visual decline of 7.1 letters (5.5 letters in monotherapy eyes, P = 0.32) and received a significantly higher number of injections (39.6 ± 9.9 vs. 24.4 ± 13.1, P < 0.0001). Patients discontinuing treatment were older and had lower baseline vision compared to completers.Conclusion:VA declined below the baseline after 10 years of follow-up and switching did not have any effect on the final visual outcome.     

雷珠单抗治疗不同疾病所致黄斑水肿的疗效观察

目的：探讨玻璃体腔注射雷珠单抗治疗因糖尿病、视网膜静脉阻塞继发黄斑水肿的安全及有效性。方法：选取2013-06/2016-02在北京航天中心医院眼科因糖尿病继发黄斑水肿( DME )和视网膜静脉阻塞继发黄斑水肿( RVO-ME)收治入院,并符合本研究纳入及排除标准的患者35例38眼,其中DME 23眼,RVO-ME 15眼。患眼接受玻璃体腔雷珠单抗(0.5mg/0.05mL)注射治疗,治疗前和治疗后1、3d,1wk、1mo定期门诊回访观察最佳矫正视力( BCVA )、黄斑中心凹厚度( CRT )、眼压。比较雷珠单抗治疗DME及RVO-ME前后的疗效。结果：DME组及RVO-ME组治疗后1、3d,1wk的BCVA均较治疗前提高,差异均有统计学意义(P<0.05),而两组1 mo的BCVA与治疗前相比差异均无统计学意义( P>0.05)。 DME组及RVO-ME组治疗后1、3d,1wk,1mo的CRT均较治疗前明显改善,差异均有统计学意义( P<0.05)。在BCVA及CRT方面比较,雷珠单抗对于RVO-ME及 DME疗效差异无统计学意义( P >0.05)。结论：玻璃体腔注射雷珠单抗对DME及RVO-ME的治疗均安全有效。     

Phase I/II randomized study of proton beam with anti-VEGF for exudative age-related macular degeneration: long-term results

Background/objectiveTo determine if treatment of exudative age-related macular degeneration (eAMD) using proton beam therapy (PBT) combined with intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is safe and effective long term.Subject/methodsThirty eyes with newly diagnosed eAMD were enrolled in a phase I/II prospective, sham-controlled double-masked university study. Eyes were randomized 1:1:1–24 GyE, 16 GyE or sham radiation, and treated with three initial monthly intravitreal ranibizumab or bevacizumab. Subsequent anti-VEGF reinjection was based on monthly optical coherence tomography and examination for 2 years and standard of care thereafter.ResultsA total of 23 eyes completed 2-year study follow-up, of which 16 maintained monthly follow-up. Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05). The 24 GyE group required fewer anti-VEGF injections when compared with the sham group at 2 years (4.67 ± 1.9 vs 9.67 ± 3.5; p = 0.017). Extended follow-up (mean 4 years) available in 22 eyes showed persistent reduced need for anti-VEGF therapy among eyes treated with 24 GyE compared with sham radiation (2.0 ± 1.6 vs 4.84 ± 2.4 per year, p = 0.008). New and increasing geographic atrophy (GA), noted in some eyes in all treatment groups, resulted in decreased mean BCVA from baseline for the 24 GyE group on extended follow-up (p = 0.009). Possible mild radiation retinopathy noted in 15% of eyes was not visually significant.ConclusionsInitial treatment combining PBT (24 GyE) with intravitreal anti-VEGF therapy appears to decrease the need for anti-VEGF reinjection in eyes with newly diagnosed eAMD. Radiation retinopathy risk was low and does not appear visually significant. Long-term vision was limited by GA development especially in the 24 GyE group.Subject terms: Macular degeneration, Outcomes research     

Six years after manual small incision cataract surgery—Perspective from a secondary level eye hospital in Rural India

Purpose:We assessed the long-term impact of manual small incision cataract surgery (MSICS) in rural Central India using patient reported outcomes (PRO).Methods:841 patients undergoing MSICS by a single surgeon from January 2012 to July 2013 were included. The same patients were contacted telephonically in November 2019 and were asked to report their perceived outcome of the cataract surgery. Data on the fellow eye status were also collected. These data were compared with objective data recorded at the time of surgery.Results:The mean age was 61.53 ± 10.9 with 59% women. 96% had presenting visual acuity (VA) ≤5/60. 86% had visually significant cataract in the fellow eye; 2.5% were cataract blind. 85% had unaided VA ≥ 6/18 at 6 weeks. 223 patients were contactable by telephone after 6 years. 55 had expired and their relatives gave the information. Of these, 90% reported “good” outcome. PRO at 6 years and unaided VA at 6 weeks after surgery correlated significantly (P = 0.05). 40% had undergone cataract surgery of the fellow eye in the interim. Of those who reported “not good” outcome, 70% had undergone fellow eye surgery, compared with 38% in those who reported “good” outcome (P = 0.005).Conclusion:Telephonic PRO correlates with unaided VA 6 years after cataract surgery and could replace a follow-up visit. A PRO of poor vision in the already operated eye was the only factor correlating with fellow eye surgery.     

Real-world outcomes of two-year Conbercept therapy for diabetic macular edema

AIM: To evaluate the two-year outcomes of patients treated for diabetic macular edema(DME) with intravitreal Conbercept(IVC).METHODS: The clinical data of 30 DME patients(36 eyes) were retrospectively reviewed. The patients were treated with IVC for 3 mo. Additional IVC was given at subsequent monthly visits, if needed(3+PRN). The patients were followed up for 24 mo.RESULTS: The best-corrected visual acuity(BCVA) at 24 mo significantly increased(66.7±15.3 letters) in comparison with the baseline(54.4±15.4 letters, P<0.0001). The mean improvement in BCVA was 11.0±2.9 letters. At 24 mo, 44.1% of the eyes surveyed gained ≥15 letters, 52.9% of the eyes gained ≥10 letters, and 70.6% of the eyes gained ≥5 letters. No vision loss was noted in 96.8% of the eyes, and 5.9% of the eyes lost ≥5 letters, but ≤10 letters. The central retinal thickness(CRT) at 24 mo was significantly reduced(277.1±122.9 μm) in comparison with the baseline(510.9±186.1 μm, P<0.0001). At 24 mo, 43.3% of the patients had a CRT ≤250 μm. The mean number of injections over 24 mo was 10.6±2.0. No severe eye or systemic adverse events related to either the drug or injection were noted.CONCLUSION: IVC is safe and effective for the treatment of DME.     

Short-term results of intravitreal bevacizumab for macular edema with retinal vein obstruction and diabetic macular edema.

OBJECTIVE: The aim of this study was to identify the short-term effect, safety, and durability of intravitreally injected bevacizumab in patients with macular edema (ME) caused by retinal vein obstruction (RVO) and diabetic macular edema (DME). METHODS: We retrospectively evaluated 39 eyes of 36 patients, 14 with ME caused by RVO and 25 with DME, who received intravitreal bevacizumab (1.25 mg) and were followed up for at least 3 months. Monthly assessments examined safety, best corrected visual acuity with an ETDRS chart (logMAR), and central retinal thickness (CRT) using optical coherence tomography. RESULTS: No significant ocular or systemic side-effects were observed. The follow-up period was 5.4 +/- 1.1 months (mean +/- standard deviation). During follow-up, the mean number of injections was 1.4 +/- 0.5. The baseline mean logMAR was 0.91 +/- 0.51, and the mean CRT was 552.6 +/- 186.7 microm. At 1, 2, and 3 months, the mean logMAR was 0.67 +/- 0.46 (paired t test, P < 0.001), 0.66 +/- 0.46 (P < 0.001), and 0.69 +/- 0.45 (P < 0.001), respectively, and the mean CRT was 323.1 +/- 151.9 mum (P < 0.001), 324.6 +/- 136.9 mum (P < 0.001), and 382.5 +/- 130.4 microm (P < 0.001), respectively. Fourteen (14) of 34 eyes with more than 3 months of follow-up required a second injection at a mean 3.4 +/- 1.0 months after the initial injection. For both ME caused RVO and DME patients, a bevacizumab administration improved logMAR and CRT at each time point through to 6 months, except for logMAR in DME at 1 week (P = 0.081), 5 months (P = 0.130) and 6 months (P = 0.759). CONCLUSIONS: An intravitreal bevacizumab injection for ME caused by RVO and DME was safe and effective for improving visual acuity and reducing CRT.