Abstract

DO.18.08

Lesion characteristics and progression in the natural history of Geographic Atrophy (GAP)-Study

Steffen Schmitz-Valckenberg1, Glenn J. Jaffe2, Monika Fleckenstein1, Petra Kozma-Wiebe3, Thomas Hohman3, Frank G. Holz1
1Universitäts-Augenklinik Bonn; 2Eye Center, Duke University, Durham, USA; 3Alcon Research Ltd., Forth Worth, USA

Objective: Geographic atrophy (GA) is a major cause of severe visual loss in patients with advanced dry age-related macular degeneration (AMD). It has a marked impact on the quality of life of the elderly population and represents a large unmet medical need. The purpose of this study is to determine the rate of progression of GA lesions over time and to assess predictive baseline characteristics in patients enrolled in a prospective, natural history study.
Methods: Inclusion criteria include age ≥ 55 years, at least a single GA lesion of =0.5 disc area (DA), a total lesion size ≤ 7 DA, best-corrected visual acuity (BCVA) of 35 letters or greater in the study eye, and drusen of ≥ 63 μm or GA in the fellow eye. Eyes were evaluated at baseline using BCVA, complete ophthalmic examination, fundus photography, fundus autofluorescence (FAF) imaging and fluorescein angiogram and at every 6 months for 18 months by FAF and fundus photography. The primary outcome measure is the anatomical enlargement rate of GA lesions quantified in FAF images.
Results: As of February 2009, recruitment is ongoing in the GAP study. Preliminary baseline data were available for 359 patients and 6-month follow-up data were available for 118 patients. At baseline the mean age of patients was 77.1 ± 7.8 years and the mean BCVA was 61.9 ± 13.9 letters. While 25.9% of eyes had unifocal GA lesions, 73.1% showed multifocal patches of GA. Abnormal perilesional FAF patterns (N=301) were classified into none (4%), focal (4%), banded (6%), patchy (2%) and diffuse (65%). The distribution of patterns was similar to that reported in the FAM study. The mean lesion size was 7.11 ± 4.93 mm2 at baseline and lesions grew on average by 0.95 ± 0.94 mm2 during 6 months as determined by FAF imaging.
Conclusions: Completion of this study will provide further understanding of the natural history of GA progression. The data will be helpful in designing future treatment trials to evaluate novel therapies for slowing progression of geographic atrophy.
Clinical Trial: www.clinicaltrials.gov NCT00599846

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