Study of Dark Adaptation in Age-Related Macular Degeneration

Summary

Participation Requirements

Description

Objective: This study is designed to investigate the use of dark adaptation as a functional endpoint for progression of eyes with no to intermediate age-related macular degeneration (AMD). Study Population: Two hundred forty (240) participants will be initially accrued; however, up to 280 participan...

Objective: This study is designed to investigate the use of dark adaptation as a functional endpoint for progression of eyes with no to intermediate age-related macular degeneration (AMD). Study Population: Two hundred forty (240) participants will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. Participants will have varying degrees of severity of AMD (Groups 0, 1, 2, 3 and 4). Group 0 (N=40) is defined as participants without AMD meaning no large drusen (greater than or equal to 125 microns) or advanced AMD in either eye. Group 1 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD (choroidal neovascularization (CNV) or geographic atrophy (GA)) in the fellow eye. Group 2 (N=40) is defined as participants with bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes. Group 3 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD (CNV or GA) in the fellow eye. Group 4 (N=40) is defined as participants with findings of reticular pseudodrusen (RPD) defined as having (1) the presence of reticular inter-lacing patterns on at least one en face imaging method (color photography, autofluorescence or infrared) and (2) confirmation of previously described findings of hyperreflective material located between the retinal pigment epithelium (RPE) and the photoreceptor ellipsoid zone on SD OCT in those areas. Current participants in this study have been graded and categorized into this cohort. Up to 40 diabetic participants will be recruited. Design: This is a single center, exploratory, observational, longitudinal evaluation of dark adaptation response in AMD participants over five years and long-term evaluation of dark adaptometry (DA) change as a predictor for AMD progression and visual acuity (VA) loss. Outcome Measures: The primary outcome is to determine mean change, including the distribution of change, in dark adaptation response between baseline and months 12 and 24 for Groups 0, 1, 2, 3 and 4. The secondary outcomes for each of the five groups are to determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 and to determine mean change in best-corrected visual acuity (BCVA) of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. Exploratory outcomes for each of the five groups are to correlate mean BCVA of the study eye with mean dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60 and to correlate AMD severity with dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60. Images from all visits may be sent to the Reading Center; however, only the baseline and annual visits are required to be graded. This study will also analyze renal function in AMD participants. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.

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