Designing clinical trials for age-related geographic atrophy of the macula: enrollment data from the geographic atrophy natural history study.
OBJECTIVE
To derive information from the Geographic Atrophy (GA) Natural History Study that is relevant to recruiting patients and designing clinical trials for GA.


METHODS
A prospective natural history study with annual follow-up enrolled patients with GA and no choroidal neovascularization (CNV) in at least one eye. Characteristics of recruited and enrolled patients are analyzed, in the context of progression data from the study.


RESULTS
The data show that GA from age-related macular degeneration (AMD) was seen in 82% of the referred patients, there was an attrition rate of 14%, and 60% of the patients with GA from AMD had bilateral GA without CNV. Within the 83 patients in the bilateral GA group with follow-up, 50 patients (60%) met both the proposed visual acuity and the proposed GA area criteria for a treatment trial in one or both eyes.


CONCLUSIONS
These data should be helpful in planning future treatment trials for GA.
Sunness
Janet S
JS
Richard E. Hoover Rehabilitation Services for Low Vision and Blindness, Greater Baltimore Medical Center, Baltimore, Maryland 21204, USA. jsunness@gbmc.org
Applegate
Carol A
CA
Bressler
Neil M
NM
Hawkins
Barbara S
BS
D001284:Atrophy; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D008266:Macula Lutea / Q000473:pathology*; D008268:Macular Degeneration / Q000175:diagnosis* / Q000628:therapy; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D014792:Visual Acuity