The purpose of this study is to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy
RRR is a phase II, randomized, multicenter, clinical study to assess the tolerability and efficacy of ranibizumab treatment administered in subjects with radiation retinopathy. Subjects will be randomized into one of 3 arms; intravitreal (IVT) monthly vs. ranibizumab treatment administered IVT monthly combined with peripheral targeted photocoagulation vs. ranibizumab treatment administered IVT for three months followed by as needed treatment of ranibizumab combined with peripheral targeted photocoagulation over 48 weeks. From week 52 to week 101, all 3 treatment arms will employ a treat and extend protocol for IVT ranibizumab treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
TRP to areas of retinal ischemia
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States
Retina Consultants of Houston
Katy, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity at 104 Weeks From Day 0.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) utilizes the ETDRS visual acuity chart to measure vision in clinical trials. Standard unit of measure is the number of letters subjects are able to read on the chart.
Time frame: 104 weeks
The Mean Number of Intravitreal Injections Required Per Subject Per Cohort.
Time frame: 104 weeks
Percentage of Subjects With Retinal Hemorrhage at 104 Weeks.
Time frame: 104 weeks
Percentage of Subjects With Intraretinal Exudates on Fundus Examination at Week 104.
Time frame: 104 weeks
Mean Change in Central Mean Thickness According to Spectral-domain Optical Coherence Tomography at Week 104 Compared to Baseline.
Spectral-domain optical coherence tomography (SD-OCT) is a common imaging modality used to visualize the layers of the macula. Central mean thickness (CMT) is the length in microns from the internal limiting membrane to Bruch's membrane.
Time frame: 104 weeks
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