Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)|
- Pre-wet AMD baseline visual acuity [ Time Frame: Monthly for 12 months ] [ Designated as safety issue: No ]% of patients that achieve their pre-wet AMD baseline vision within 12 months
- Mean change in BCVA at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12-month time frame ] [ Designated as safety issue: No ]Mean change in BCVA at 6 and 12 months
- Mean change in CFT at 6 and 12 months [ Time Frame: Month 6 and Month 12 in 12-month study time frame ] [ Designated as safety issue: No ]Mean change in CFT at 6 and 12 months
- Genome variations contributing to onset, progression and severity of CNV. [ Time Frame: End of 12-month study time frame ] [ Designated as safety issue: No ]Genome variations contribution/prediction to onset, progression and severity of CNV (lesion size and BCVA), the efficacy of treatment relative to gene status.
|Study Start Date:||July 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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
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).
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Kang Zhang, MD, PhD||University of California, San Diego|