Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00668785|
Recruitment Status : Terminated (Study was terminated due to low enrollment)
First Posted : April 29, 2008
Results First Posted : April 24, 2015
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy Macular Edema||Drug: ranibizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)|
|Study Start Date :||March 2007|
|Primary Completion Date :||June 2010|
|Study Completion Date :||March 2012|
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.
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: Lucentis
- 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 ]No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.
- 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 ]
- Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point [ Time Frame: March 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668785
|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.|