Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
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|ClinicalTrials.gov Identifier: NCT00387582|
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy Diabetic Macular Edema||Drug: Ranibizumab (Lucentis) Procedure: Argon Laser||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lucentis in the Treatment of Macular Edema - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab Versus Focal Laser Treatment in Subjects With Diabetic Macular Edema|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Lucentis injections for the first three months of the study and then per the protocol for the duration of the trial.
Drug: Ranibizumab (Lucentis)
Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.
Other Name: NDC # 50242-0080-01, Brand Name is Lucentis
Active Comparator: II
Argon Laser treatment at enrollment and then per the protocol for the duration of the study.
Procedure: Argon Laser
Argon laser at entry to trial and then per protocol for the duration of the study.
- Prevention of vision loss at one year as evidenced by ETDRS visual acuity. [ Time Frame: 6 and 12 months ]
- Reduction in retinal thickening based on Optical Coherence Tomography. [ Time Frame: 6 and 12 months ]
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): NCT00387582
|United States, Utah|
|Rocky Mountain Retina Consultants|
|Salt Lake City, Utah, United States, 84107|
|Principal Investigator:||Roy A. Goodart, MD||Rocky Mountain Retina Consultants|