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Periocular triamcinolone and photodynamic therapy for subfoveal choroidal neovascularization in age-related macular degeneration.

Author(s): Neovascular Age-Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy (NAPP) Trial Research Group, Gilson MM, Bressler NM, Jabs DA, Solomon SD, Thorne JE, Wilson DJ

Affiliation(s): Johns Hopkins University, Baltimore, Maryland, USA.

Publication date & source: 2007-09, Ophthalmology., 114(9):1713-21.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: To evaluate fluorescein angiographic and visual acuity (VA) outcomes from patients enrolled in a trial of a single periocular corticosteroid injection immediately before photodynamic therapy (PDT) versus PDT alone for subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). DESIGN: Randomized 2-center clinical trial. PARTICIPANTS: Sixty-seven subjects with AMD, subfoveal choroidal neovascularization, and best-corrected VA of 20/20 to 20/320 in the study eye who had received no more than 1 prior PDT treatment. METHODS: Subjects were randomized to receive PDT alone (no corticosteroid) or a single periocular corticosteroid injection given via the posterior superior sub-Tenon's capsule route before PDT (corticosteroid) and assessed 1, 3, and 6 months after enrollment. Best-corrected VA and intraocular pressure (IOP) measurements were taken during each examination. Color photographs and fluorescein angiograms were taken at baseline and 3 and 6 months. MAIN OUTCOME MEASURE: Presence or absence of fluorescein leakage from choroidal neovascularization 3 months after randomization. RESULTS: Between the 34 participants randomized to periocular corticosteroid and 33 to no corticosteroid, baseline features appeared balanced. Thirty-three corticosteroid participants and 30 no corticosteroid participants returned for the 3-month follow-up, at which time 56 had fluorescein leakage. Proportions of participants with leakage at 3 months for the 2 treatment groups did not statistically significantly differ; 94% of the corticosteroid group and 90% of the no corticosteroid group had fluorescein leakage at 3 months (P = 0.66). Mean VAs at 3 months after enrollment were 20/100 and 20/125 in the corticosteroid and no corticosteroid groups, respectively, decreasing on average 1.5 and 0.9 lines from baseline (P = 0.50). Adverse events included IOP > 21 mmHg in 7 corticosteroid participants (21%) and 1 (3%) no corticosteroid participant (P<0.05) and ptosis of the study eyelid in 1 (3%) corticosteroid participant. CONCLUSIONS: In contrast to previously reported uncontrolled studies and 1 controlled study, this trial did not find a reduction in the amount of fluorescein leakage 3 months after a single periocular injection of corticosteroid and PDT compared with PDT alone.

Page last updated: 2007-10-18

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