Status:
TERMINATED
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Lead Sponsor:
Jumper, J. Michael, M.D.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Proliferative Diabetic Retinopathy
Macular Edema
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 pos...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00668785
Start Date
March 1 2007
End Date
March 1 2012
Last Update
March 5 2019
Active Locations (1)
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1
West Coast Retina Medical Group Inc.
San Francisco, California, United States, 94107