This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).
This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration. The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
108
Northern California Retina Vitreous Associates
Mountain View, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Elman Retina
Baltimore, Maryland, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Development of exudative AMD
Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)
Time frame: 2 years
Vision change
Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months
Time frame: 2 years
Vision loss
Proportion of eyes losing \< 5, 10, and 15 letters on EDTRS chart at 12 and 24 months
Time frame: 2 years
Number of injections
Number of injections required in eyes that convert from dry to wet AMD during the study period
Time frame: 2 years
Baseline predictive factors
Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD
Time frame: 2 years
Development of geographic atrophy (GA)
Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).
Time frame: 2 years
Ocular adverse events
Incidence and severity of ocular adverse events, as identified by eye examination and imaging
Time frame: 2 years
Systemic adverse events
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Incidence and severity of other adverse events, as identified by physical examination or subject reporting.
Time frame: 2 years