Comparison of early retreatment with the standard regimen in verteporfin therapy of neovascular age-related macular degeneration

Michels, S. and Wachtlin, J. and Gamulescu, Maria Andreea and Heimann, H. and Prunte, C. and Inhoffen, W. and Krebs, I. and Schmidt-Erfurth, Ursula (2005) Comparison of early retreatment with the standard regimen in verteporfin therapy of neovascular age-related macular degeneration. OPHTHALMOLOGY, 112 (12). pp. 2070-2075. ISSN 0161-6420,

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Abstract

Purpose: To compare the efficacy and safety of early retreatment with verteporfin therapy with that of approved standard verteporfin therapy in neovascular age-related macular degeneration. Design: Prospective, randomized, multicenter clinical trial. Participants: Two hundred three patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. Methods: Throughout the first 6 months of follow-up, patients received retreatment with verteporfin therapy either every 2 months (group A) or 3 months (group B). From 6 to 12 months, both groups received retreatment at 3-month intervals. Main Outcome Measures: The primary outcome of the study was best-corrected mean visual acuity as measured using the Early Treatment Diabetic Retinopathy Study protocol. The secondary outcomes were percentage of patients losing at least 3 lines of vision, percentage of patients gaining at least 1 line of vision, and lesion size based on the greatest linear dimension (GLD) documented by fluorescein angiography, impact of initial lesion size, and retreatment rate as well as safety. Results: Visual acuity was similar in both groups at baseline with a mean visual acuity of 20/100(-1). During the 12 months of follow-up, mean visual acuity was better in the early retreatment group at all intervals; however, no statistically significant benefit was seen in the overall population at anytime (P > 0.1). At month 12, mean visual acuity was 20/160(+1) in group A and 20/160(-1) in group B. There was a trend for better outcomes in the early retreatment group with regard to loss of less than 3 lines of vision at 12 months (61% vs. 51.7%). No statistically significant difference was seen with regard to lesion size for either group throughout follow-up with a final GLD of the lesion of 2790 mu m (group A) and 2996 mu m (group B). However, subgroup analysis indicated a statistically relevant benefit (P <= 0.004) for patients with small lesions (GLD < 2000 mu m) at baseline receiving early retreatment. Conclusions:. Early retreatment in 2-month intervals did not show a significant overall benefit at 1 year of follow-up compared with the standard regimen. However, smaller lesions seemed to benefit from early retreatment with verteporfin therapy in contrast to larger lesions.

Item Type: Article
Uncontrolled Keywords: SUBFOVEAL CHOROIDAL NEOVASCULARIZATION; PHOTODYNAMIC THERAPY; LESION SIZE; MACULOPATHY; PREVALENCE; SECONDARY; TRIAL; TAP;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Augenheilkunde
Depositing User: Dr. Gernot Deinzer
Date Deposited: 20 Apr 2021 11:36
Last Modified: 20 Apr 2021 11:36
URI: https://pred.uni-regensburg.de/id/eprint/35388

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