This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intravitreal ranibizumab (2.0 mg)
The New York Eye Cancer Center
New York, New York, United States
Number of participants with adverse events (allergy, infection, or change in vital signs)
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Time frame: Baseline, at day 7, then monthly
Number of participants with changes in central foveal thickness
This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Time frame: Monthly, Report at Month 12
Number of participants with changes in visual acuity
Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Time frame: Monthly, Report at Month 12
Number of injections each group (arm) has received
Each group (arm) will be assessed for the number of monthyl injections received through Month 12.
Time frame: Monthly, Report at Month 12
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.
Time frame: Monthly Report at Month 12
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