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.
Proliferative Diabetic Retinopathy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)|
- Mean change from pre-PRP best corrected visual acuity (BCVA) at 3 months as expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) score (number of letters correctly read.) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Mean change from pre-PRP Optical Coherence Tomography (OCT) in central foveal thickness and macular volume as assessed by OCT at 1, 2 and 3 months. [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Percentage of patients that maintain pre-PRP visual acuity at the 3 month time point [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Change between baseline and each efficacy outcome assessment in best-corrected ETDRS visual acuity score (e.g. mean visual acuity score) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Change in the hyperfluorescence of the macula as assessed by 2 readers blinded to the 2 arms of the study. [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
- Injection-related events including severe uveitis, infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Other Name: LucentisDrug: Ranibizumab
Ranibizumab 0.5mg at baseline, then again at 30 days and/or 60 days post PRP per Investigator discretion.
Other Name: Lucentis
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.
|United States, California|
|West Coast Retina Medical Group Inc.|
|San Francisco, California, United States, 94107|
|Principal Investigator:||J. Michael Jumper, M.D.||West Coast Retina Medical Group, Inc.|