Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
|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: NCT01571232|
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema Non-proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy||Drug: dexamethasone intravitreal implant Drug: intravitreal bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.|
|Study Start Date :||April 2012|
|Primary Completion Date :||February 2014|
|Study Completion Date :||March 2015|
Active Comparator: Ozurdex
Patients in this group receive Ozurdex at initial visit and at month 4
Drug: dexamethasone intravitreal implant
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Other Name: Ozurdex
Active Comparator: Avastin
Patients in this group receive Avastin Q1 month for 5 months.
Drug: intravitreal bevacizumab
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Other Name: Avastin
- The Change in Visual Acuity (Number of ETDRS Letters). [ Time Frame: 6 months ]The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
- The Change in Central Foveal Thickness (Microns on High Resolution OCT). [ Time Frame: 6 months ]The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
- The Change in Macular Leakage on Fluorescein Angiography From Baseline [ Time Frame: 6 months ]To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
- The Change in Mean Macular Sensitivity on Microperimetry From Baseline [ Time Frame: 6 months ]To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
- The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. [ Time Frame: 6 months ]To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
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): NCT01571232
|United States, California|
|Retina Macula Institute|
|Torrance, California, United States, 90503|
|Principal Investigator:||Ron P Gallemore, M.D, Ph.D||Retina Macula Institute|