To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration
Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment groups: Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator (observing investigators will remain masked). Subjects in the treatment group will receive a 2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to crossover to treatment with a single dose of Luminate®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Subjects injected intravitreally with 1.0mg of Luminate®
Sham injection
Derek Kunimoto
Gilbert, Arizona, United States
Derek Kunimoto
Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Change in BCVA
1\. Percentage of population with ≥ 8 letters (1 ½ lines) BCVA gain in the Luminate group (Treatment group 1 that received 2 doses of Luminate) from baseline to study week 28 vs the Sham control group from baseline to study week 12
Time frame: 8 month total study including crossover
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Raj Maturi
Indianapolis, Indiana, United States
Valley Retina Institute
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States