This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).
RBM-007 is a novel oligonucleotide-based aptamer having potent anti-FGF2 activity and anti-VEGF-expression activity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
RBM-007 Injectable Solution
EYLEA® (aflibercept) Injection, for Intravitreal Use
Sham intravitreal injection
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Advanced Research, LLC
Coral Springs, Florida, United States
Visual Acuity - Continuous
Mean change in Best Corrected Visual Acuity from Baseline to Week 16
Time frame: Week 16
Visual Acuity - Categorical
Percentage of patients gaining \>= 15 letters as measured by Best Corrected Visual Acuity from Baseline at Week 16
Time frame: Week 16
Macular Thickness Change
Change from Baseline in Central Subfield Thickness by spectral domain optical coherence tomography at Week 16
Time frame: Week 16
Macular Volume Change
Change from Baseline in macular volume by spectral domain optical coherence tomography at Week 16
Time frame: Week 16
Fibrosis Change
Change from Baseline in sub-retinal hyper-reflective material by spectral domain optical coherence tomography at Week 16
Time frame: Week 16
Safety - Ocular
Ocular examination (biomicroscopy and ophthalmoscopy) at Week 20 - Number of participants with additional corneal abnormalities
Time frame: Week 20
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Georgia Retina, P.C.
Marietta, Georgia, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States