Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
|ClinicalTrials.gov Identifier: NCT01402544|
Recruitment Status : Terminated (Per study sponsor decision.)
First Posted : July 26, 2011
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: ranibizumab||Phase 2 Phase 3|
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.
Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Ranibizumab 0.5 mg
Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year
0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Other Name: Lucentis
- Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months [ Time Frame: Baseline, Month 6 and Month 12 ]PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.
- Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. [ Time Frame: Baseline, Month 6 and Month 12 ]Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.
- Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months [ Time Frame: Baseline, Month 6 and Month 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402544
|United States, California|
|California Retina Consultants|
|Bakersfield, California, United States, 93309|
|Shiley Eye Center, UCSD|
|La Jolla, California, United States, 92093|
|California Retina Consultants|
|Santa Barbara, California, United States, 93103|
|United States, Texas|
|Medical Center Ophthalmology Associates|
|San Antonio, Texas, United States, 78240|
|Study Chair:||Henry Ferreyra, MD||University of California, San Diego|