Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
|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|
|Actual Primary Completion Date :||February 2014|
|Actual 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.
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|