Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept
This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 12 months.
Exudative Macular Degeneration
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Single Arm, Investigator Initiated Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Injection in Subjects With Exudative AMD Previously Treated With Ranibizumab or Bevacizumab (ASSESS Study)|
- Central Foveal Thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]The mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT
- Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]The mean absolute change from baseline in best-corrected visual acuity score at months 6 and 12 as measured by ETDRS protocol
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
The purpose of this study is to examine the use of Aflibercept in patients who have been previously treated with Ranibizumab or Bevacizumab for exudative macular degeneration. Specifically, we will examine its effect on macular degeneration, measured by SDOCT (Spectral Domain Optical Coherence Tomography) and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity. This will be a prospective study with patients to receive an intravitreal injection of Aflibercept at the time of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617148
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Rishi P Singh, MD||The Cleveland Clinic|