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.
- Pre-PRP protocol refraction, fluorescein angiography, and optical coherence
tomography AND 7-14 day post-PRP OCT
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age 21 years or older
- Previously untreated PDR patients with high risk characteristics who develop edema
within 7-14 days post PRP therapy. This edema, determined by a masked investigator,
will be characterized as either increased foveal thickness (>10% increase from
pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from
pre-PRP macular volume).
- Pregnancy (positive pregnancy test) prior to enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial
- Pre-PRP clinically significant diabetic macular edema (CSME) that would make the
patient eligible for macular laser prior to PRP
- Neovascularization of the iris or neovascular glaucoma
- Increased central foveal thickness for any other reason
- Concurrent macular diseases that could confound the results of this study
- Prior vitrectomy in the study eye
- Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab,
bevacizumab or triamcinolone acetonide