Macular Edema Clinical Trial
Official title:
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.
Levels of VEGF are elevated in eyes wth Diabetic Macular Edema and the expression of VEGF was
found to be elevated temporarily following the photocoagulation of human Retinal Pigment
Epithelial (RPE) cells. Ranibizumab (Lucentis TM, Genentech) is an anti-VEGF antibody shown
to have properties to prevent macular edema. We hypothesize that VEGF inhibition can
effectively treat PRP-induced macular edema, thereby minimizing post-PRP vision loss.
Subjects who meet eligibility criteria will receive 0.5mg ranibizumab administered 7-14 days
post-PRP. Additional intravitreal injections of 0.5 mg of ranibizumab at Day 30 and/or Day 60
may be also be administered. All subjects will be followed for 90 days for safety and
efficacy assessments. There is no placebo or sham arm of this trial.
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