Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Stopped early · Phase 2

Conditions studied: Proliferative Diabetic Retinopathy, Macular Edema

In brief

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.

Key facts

Study ID

NCT00668785

Run by

Jumper, J. Michael, M.D.

People needed

6

Starts

2007-03-01

Expected to finish

2012-03-01

Last updated by the study team

2019-03-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• West Coast Retina Medical Group Inc. — San Francisco, California, United States

Full record on ClinicalTrials.gov

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