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Sponsors and Collaborators: |
Jumper, J. Michael, M.D. Genentech |
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Information provided by: | Jumper, J. Michael, M.D. |
ClinicalTrials.gov Identifier: | NCT00668785 |
This is a randomized, open-label Phase II study evaluating the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.
Condition | Intervention | Phase |
---|---|---|
Proliferative Diabetic Retinopathy Macular Edema |
Drug: ranibizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II) |
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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 be randomized to either ranibizumab 0.5mg or observation at a ratio of 2:1. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer M Rose, B.S. | 415-972-4608 | jrose@westcoastretina.com |
Contact: Brandi L. Teske | 415-972-4606 | bteste@westcoastretina.com |
United States, California | |
West Coast Retina Medical Group Inc. | Recruiting |
San Francisco, California, United States, 94107 | |
Contact: Jennifer M Rose, B.S. 415-972-4608 jrose@westcoastretina.com | |
Contact: Brandi L Teske 415-972-4606 bteske@westcoastretina.com | |
Sub-Investigator: Robert N Johnson, M.D. | |
Sub-Investigator: H. Richard McDonald, M.D. | |
Sub-Investigator: Arthur D Fu, M.D. | |
Sub-Investigator: Alex T Bui, M.D. | |
Sub-Investigator: Richard Roe, M.D. |
Principal Investigator: | J. Michael Jumper, M.D. | West Coast Retina Medical Group, Inc. |
Responsible Party: | West Coast Retina Medical Group, Inc. ( Jumper, J. Michael, M.D. ) |
Study ID Numbers: | FVF3848s |
Study First Received: | April 25, 2008 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00668785 |
Health Authority: | United States: Food and Drug Administration |
Ranibizumab Proliferative Diabetic Retinopathy Macular Edema following Panretinal Photocoagulation Safety and Efficacy Intravitreal Injection |
Eye Diseases Vascular Diseases Diabetes Mellitus Edema Endocrine System Diseases Macular Degeneration Retinal Degeneration Diabetic Angiopathies |
Macular Edema Signs and Symptoms Diabetic Retinopathy Endocrinopathy Retinal Diseases Diabetes Complications Retinal degeneration |
Cardiovascular Diseases |