Safety profile of intravitreal triamcinolone acetonide.

BACKGROUND: There is currently a widespread use of intravitreal triamcinolone acetonide (IVTA) for age-related macular degeneration, diabetic macular edema, cystoid macular edema secondary to retinal vein occlusions, and uveitis. The aim of this investigation was to assess the rates of various complications associated with this treatment and to determine which factors are associated with the development of these complications. METHODS: A retrospective interventional case series of all patients from one retina specialist undergoing IVTA was conducted in a clinical setting from 2002 to 2005. All disease entities were included. Patients were followed for a mean of 9.5 months after receiving 4 mg (0.1 mL) of nonfiltered triamcinolone acetonide (TA). All complications associated with the injection procedure or with the TA were noted. RESULTS: Two hundred and twenty-three (223) eyes of 192 patients received a total of 336 IVTA injections between 2002 and 2005. The mean age was 73.3 years and mean follow-up was 9.5 months. A single injection was performed in 144 eyes (64.6%); 2 IVTAs in 55 eyes (24.7%); 3 IVTAs in 16 eyes (7.2%), and 3.6% of eyes had more than 3 injections at a minimal interval of 3 months. The only immediate complication was a single injection (0.3%) associated with a temporary occlusion of the central retinal artery, which opened immediately following anterior paracentesis. Late complications included endophthalmitis in 1 of 336 (0.3%) injections and a steroid response requiring glaucoma medication in 60 of 192 patients (31.3%). In patients with preexisting glaucoma, 58.8% required additional glaucoma medication. Glaucoma-filtering surgery was required in 2 of 192 patients (1.0%). CONCLUSIONS: In the study center, the IVTA is extremely safe in patients without a history of glaucoma. However, patients with preexisting glaucoma with progressive optic neuropathy must be treated with great caution.     

Safety of intravitreal high-dose reinjections of triamcinolone acetonide

PURPOSE: To report side effects after intravitreal high-dose reinjections of triamcinolone acetonide. DESIGN: Clinical interventional case series. METHODS: Forty-six patients (47 eyes) received at least two intravitreal injections of approximately 20 to 25 mg triamcinolone acetonide for treatment of diabetic macular edema (n = 6 eyes), exudative age-related macular degeneration (n = 23), and other diseases. Intervals between injections were 6.7 +/- 3.4 months, 8.0 +/- 4.6 months, and 10.2 months, respectively, before the second (n = 47 eyes), third (n = 9), and fourth (n = 2) injection. Mean follow-up was 20.7 +/- 8.9 months. RESULTS: After no reinjection were complications detected, other than those known to occur after a single intravitreal injection. After the first, second, and third injection, respectively, intraocular pressure remained normal in 24 (51%), 25 (53%), and 5 (56%) eyes. CONCLUSIONS: Intravitreal high-dosage reinjections of triamcinolone acetonide may be tolerated within a mean follow-up of approximately 21 months.     

小剂量曲安奈德玻璃体腔重复注射的安全性观察

目的评价小剂量曲安奈德玻璃体腔内重复注射的安全性。设计前瞻性、非对照干预研究。研究对象31例(31眼),包括黄斑水肿16例、糖尿病性黄斑水肿6例、渗出型老年黄斑变性4例、中央或分支视网膜静脉阻塞3例和非感染性葡萄膜炎2例。方法4mg曲安奈德玻璃体腔内重复注射,在距首次注射分别(2.9±1.1)个月和(4.5±2.5)个月时,分别进行了第2次(31眼)和第3次(9眼)注射,每次注射后监测视力和眼内压等。平均随访(8.4±1.6)个月。主要指标眼压、视力。结果相对于曲安奈德玻璃体腔内单次注射,重复注射并未导致特殊并发症发生。在第1、2、3次注射后分别有23(74.2%)、24(77.4%)和7(77.8%)眼眼压保持正常。3次注射后(每次)眼压的平均值之间比较无显著统计学差异。2眼(6.5%)白内障进展迅速需手术治疗。结论短期随访,小剂量曲安奈德玻璃体腔内重复注射对眼压等无明显影响。     

Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection

PURPOSE: To describe the pharmacokinetics occurring after the direct injection of triamcinolone acetonide into the vitreous humor of humans. DESIGN: Interventional case series. PARTICIPANTS: Five patients who received a single 4-mg intravitreal injection of triamcinolone acetonide. METHODS: An aqueous humor sample was obtained from 5 eyes via an anterior chamber paracentesis at days 1, 3, 10, 17, and 31 after injection. At each visit, visual acuity and intraocular pressure were measured and indirect ophthalmoscopy was performed. A fluorescein angiogram was carried out at day 10. Concentrations were determined using high performance liquid chromatography; pharmacokinetic analysis was carried out using PK Analyst, an iterative, nonlinear, weighted, least-squares regression program. MAIN OUTCOME MEASURES: Intraocular concentrations of triamcinolone were measured and population pharmacokinetic parameters were calculated. RESULTS: Pharmacokinetic data followed a two-compartment model. Peak aqueous humor concentrations ranged from 2151 to 7202 ng/ml, half-lives from 76 to 635 hours, and the integral of the area under the concentration-time curve (AUC(0-t)) from 231 to 1911 ng/h per milliliter. After a single intravitreal injection of triamcinolone, the mean elimination half-life was 18.6 days in nonvitrectomized patients. The half-life in a patient who had undergone a vitrectomy was shorter at 3.2 days. CONCLUSIONS: There was considerable intrasubject variation among peak concentration, AUC(0-t) values, and elimination half-lives. After intravitreal injection, measurable concentrations of triamcinolone would be expected to last for approximately 3 months (93 +/- 28 days) in the absence of a vitrectomy. Because triamcinolone pharmacokinetics were characterized only in elderly patients with macular edema, the results cannot be extrapolated to other patient populations.     

Safety and efficacy of intravitreal triamcinolone acetonide for uveitic macular edema

BACKGROUND: To evaluate the safety and efficacy of intravitreal triamcinolone acetonide (TA) for treating macular edema secondary to non-infectious uveitis. METHODS: Retrospective review of sixteen patients (20 eyes) with chronic cystoid macular edema (CME) as a consequence of controlled intermediate uveitis, posterior uveitis, or panuveitis who received at least one intravitreal injection of TA. Main outcome measures were visual acuity (VA), intraocular pressure (IOP), formation or progression of an existing cataract, and CME resolution during the follow-up period. RESULTS: At last follow-up, VA showed improvement (compared to baseline) in 11 eyes (55%), deterioration in three eyes (15%), remained completely unchanged in one eye (5%), and showed improvement initially but returned to baseline levels in five eyes (25%). At last follow-up, CME had relapsed or was still present in 10 of the eyes (50%). The remaining eyes showed complete resolution of the CME, without evidence of recurrence during the follow-up time. Mean VA at last follow-up showed statistically significant improvement (p = 0.02) in nonvitrectomized eyes (mean baseline VA: 1.14 +/- 0.58; mean final VA: 0.96 +/- 0.66) compared to the almost unaltered mean visual acuity for vitrectomized eyes (mean baseline VA: 0.76 +/- 0.41; mean final VA: 0.71 +/- 0.48)(p = 0.40, paired samples t-test). Elevation of IOP was transient in all cases and responded well to topical medications, except for one patient who required placement of an Ahmed valve. Preexisting cataract progressed in three of the 15 phakic eyes (20%). One patient developed a retinal detachment and required additional surgery to reattach it. Patients were followed for a mean of 34 weeks (median: 32 weeks; range: 19-56 weeks). CONCLUSIONS: Intravitreal TA may play a role in the treatment of uveitis-related CME. Further controlled studies are necessary to test this hypothesis.     

Intravitreal preservative-free triamcinolone acetonide for the treatment of macular oedema

PURPOSE: To report the use of commercially available preservative-free intravitreal triamcinolone acetonide for the treatment of macular oedema due to retinal vascular diseases. DESIGN: Retrospective interventional case series. METHODS: Charts of eyes that received 4 mg preservative-free intravitreal triamcinolone acetonide for the treatment of persistent macular oedema due to retinal vascular diseases were reviewed. Patients were included if they had a follow-up of at least 3 months. Visual acuity, intraocular pressure, presence of an anterior chamber reaction, and mean macular thickness on optical coherence tomography (OCT) were recorded. RESULTS: A total of 10 eyes of 10 patients were identified. Visual acuity improved by a mean of 1.1 Snellen lines at 1 month and 1.3 lines at 3 months. Macular thickness on OCT decreased by a mean of 183.5 microm at 1 month (P<0.0001). Intraocular pressure increased from a mean of 13.5 mmHg at baseline to 15.3 at 1 month, and 14.5 at 3 months. Only the 1-month change in intraocular pressure was statistically significant (P=0.0274). There were no cases of endophthalmitis, anterior chamber reaction, or retinal detachment. CONCLUSION: In this small retrospective, noncomparative series, commercially available preservative-free intravitreal triamcinolone acetonide had no adverse outcomes. Macular oedema was noted to decrease following treatment.     

曲安奈德预防术后增殖性玻璃体视网膜病变临床观察

目的：评价曲安奈德（triamcinolone acetonidem,TA）在预防玻璃体切除术后增殖性玻璃体视网膜病变（proliferative vitreoretinopathy,PVR）发生过程中的安全性和有效性。方法：2004-03／2004-10行玻璃体手术治疗视网膜脱离患者75例78眼,分为治疗组与对照组各39眼。治疗组术中玻璃体腔内注入TA0．5-1mL（4mg）,对视网膜表面残存的玻璃体进行标识,将黏附曲安奈德的玻璃体皮质完全剥除。手术结束玻璃体腔内再注入TA0．1mL4mg）。对照组未用TA。平均随访6．8mo,两组结果进行对比分析。结果：治疗组与对照组术后PVR发生率分别是8％和28％,有显著性差异（P〈0．05）。治疗组术后视网膜脱离复发率5％,对照组为20％,有显著性差异（P〈0．05）。术后2mo眼压≥21mmHg分别是31％和13％,有显著性差异（P〈0．05）。两组手术前后视力的变化无差异。未见明显与药物有关的眼部并发症。结论：曲安奈德可以帮助显示透明的玻璃体皮质,容易辨认和剥除,提高手术安全性及成功率。有抗炎和抗增殖的作用,可以预防PVR的发生。     

Management of iatrogenic intravitreal triamcinolone acetonide

Intravitreal corticossteroids have been used for therapeutic purposes in optimum doses and adverse reports have not been described. To best of our knowledge, this entity has never been reported as a problem. We report a case of successful management of iatrogenic intravitreal triamcinolone acetonide for intermediate uveitis. This case study highlights the strategy of appropriate and timely surgical management.     

Pseudohypopyon following intravitreal triamcinolone acetonide injection

OBJECTIVE: To report a case of a pseudohypopyon that developed after intravitreal injection of triamcinolone acetonide for choroidal neovascularization from age-related macular degeneration. METHODS: Observational case report. RESULTS: A 62-year-old woman received an intravitreal injection of triamcinolone acetonide for the treatment of a choroidal neovascular membrane that developed as a result of age-related macular degeneration. A layer of yellowish deposits was observed in the anterior chamber 1 day after the injection. The patient denied any pain or reduced vision, and there was no redness noted on examination. The deposits cleared spontaneously on the fourth postoperative day. CONCLUSIONS: Pseudohypopyon may develop after intravitreal injection of triamcinolone acetonide. Distinguishing this from a true hypopyon is important because the treatment and prognosis are very different for the two conditions.     

Complications of intravitreal injection of triamcinolone acetonide

BACKGROUND: Intravitreal injection of triamcinolone acetonide appears to be a promising treatment for a variety of proliferative, edematous, neovascular and inflammatory ocular disorders. Reported complications include intraocular pressure (IOP) elevation, cataract formation, retinal detachment, vitreous hemorrhage and endophthalmitis. The purpose of this investigation was to report the complications of intravitreal triamcinolone injection that may be attributable to the injection procedure or to the corticosteroid suspension. METHODS: A total of 212 eyes of 180 patients who underwent intravitreal triamcinolone acetonide injection for various indications were enrolled. All patients received 8 mg/0.2 mL of triamcinolone. A total of 270 injections were performed by the same surgeon under topical anesthesia. The patients were followed for a mean of 9.2 months. Complications related to the injection procedure and to the corticosteroid were recorded. RESULTS: The most common complication encountered during follow-up was transient elevation of the IOP above 21 mm Hg (44 eyes [20.8%]). The average IOP rose by 28.5%, 38.2%, 16.7% and 4.2% from baseline at 1, 3, 6 and 9 months respectively. The mean IOP values at 1, 3 and 6 months were statistically significantly higher than the mean preinjection value (p < 0.001). Fourteen eyes (6.6%) had cataract progression and underwent cataract surgery with intraocular lens implantation. Endophthalmitis developed in one eye (0.5%); the patient underwent vitrectomy with silicone oil injection. Pseudoendophthalmitis occurred in one eye (0.5%), and pseudohypopyon was observed in two eyes (0.9%). INTERPRETATION: Intravitreal triamcinolone injection was effective in a variety of ocular disorders. Patients should be monitored closely given the potential for complications of the injection procedure or the corticosteroid suspension.     

Safety of intravitreal triamcinolone acetonide:an electrophysiologic and histopathological study in rabbits

AIM

To evaluate the retinal safety of various doses of intravitreal triamcinolone acetonide (TA) in rabbits.

Methods

Thirty New Zealand albino rabbits were divided into five groups (six animals each). In group 1 (control group), each animal received a single intravitreal injection of 0.1mL phosphate buffered saline. In groups 2, 3, 4 and 5, each rabbit received a single intravitreal injection of 4, 8, 16 and 32mg of TA, respectively. Each dose was contained in 0.1mL phosphate buffered saline. Clinical ocular examinations were performed before the injection and on the 1st, 3rd, 10th and 17th post-injection days. A standard dark adapted electroretinogram (ERG) was obtained before injection and on the 3rd, 10th and 17th post-injection days. After 17d, animals were sacrificed and their eyes prepared for pathological examination.

RESULTS

By monitoring ERG as a functional index for the retina, intravitreal injection of 4mg TA showed no significant ERG changes. At doses of 8, 16 and 32, hyper-abnormal responses in a- and b- waves of ERG were detected on the 3rd post-injection day. These changes gradually returned back to normal limits after 17d. Histopathological examination of the retina of all animals showed no pathological changes.

CONCLUSION

High doses of intravitreal TA seemed to have enhancing effects on the retinal function with gradual return to normal limits with no pathological changes detected in examined eyes.     

Safety of intravitreal triamcinolone acetonide:an electrophysiologic and histopathological study in rabbits

AIM: To evaluate the retinal safety of various doses of intravitreal triamcinolone acetonide (TA) in rabbits.Methods: Thirty New Zealand albino rabbits were divided into five groups (six animals each). In group 1 (control group), each animal received a single intravitreal injection of 0.1mL phosphate buffered saline. In groups 2, 3, 4 and 5, each rabbit received a single intravitreal injection of 4, 8, 16 and 32mg of TA, respectively. Each dose was contained in 0.1mL phosphate buffered saline. Clinical ocular examinations were performed before the injection and on the 1st, 3rd, 10th and 17th post-injection days. A standard dark adapted electroretinogram (ERG) was obtained before injection and on the 3rd, 10th and 17th post-injection days. After 17d, animals were sacrificed and their eyes prepared for pathological examination.RESULTS:By monitoring ERG as a functional index for the retina, intravitreal injection of 4mg TA showed no significant ERG changes. At doses of 8, 16 and 32, hyper-abnormal responses in a- and b- waves of ERG were detected on the 3rd post-injection day. These changes gradually returned back to normal limits after 17d. Histopathological examination of the retina of all animals showed no pathological changes.CONCLUSION: High doses of intravitreal TA seemed to have enhancing effects on the retinal function with gradual return to normal limits with no pathological changes detected in examined eyes.