Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-related Macular Degeneration
- Sponsor
- University of California, San Francisco
- Enrollment
- 65
- Locations
- 12
- Primary Endpoint
- visual acuity 20/70 or better
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.
Detailed Description
This is a cross-sectional cohort study of exudative age-related macular degeneration (AMD) patients seven or more years after initiation of the intravitreal ranibizumab regimen in the treatment arms of the pivotal ANCHOR or MARINA studies, who had subsequent follow up in the HORIZON Study. While the MARINA and ANCHOR studies established the benefit of ranibizumab at 2 years, many patients in the U.S. have now undergone treatment for many years, and the longer-term outcomes for this chronic disease remain unknown. Despite earlier hopes for limited duration treatment, subsequent clinical experience suggests that many patients require continued treatment. The patient population for this study is unique, in that the patients in the treatment arms of MARINA and ANCHOR are some of the earliest treated patients, providing the longest-term data available for AMD patients receiving ranibizumab. Patients recalled into this study will be evaluated to provide an update on their current visual acuity, disease activity status, anatomic characteristics, and genotype. There is a single study visit to extend the clinical history and to perform vision testing, ophthalmologic examination, and retinal imaging studies, including high-resolution spectral-domain OCT and fundus autofluorescence imaging, technologies unavailable at the time of the original ANCHOR and MARINA Trials. Genetic analysis will be performed for known AMD risk genes as well as candidate genes to study genotypic profiles associated with AMD disease progression and long-term treatment response. Understanding the course of 7-plus years of current generation AMD treatment will serve physicians in the ongoing management of this chronic disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •previous participants in the ANCHOR or MARINA studies, and...
- •who were assigned to one of the ranibizumab treatment arms, and...
- •who were enrolled in the HORIZON extension study with a current SEVEN UP investigator
- •ability to provide written informed consent and comply with study assessments
Exclusion Criteria
- •any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial
Outcomes
Primary Outcomes
visual acuity 20/70 or better
Time Frame: at date of study visit
percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)
Secondary Outcomes
- central geographic atrophy(date of study visit)
- mean change in visual acuity(at study visit)
- visual acuity 20/40 or better(at date of study visit)
- visual acuity 20/200 or worse(at date of study visit)
- exudative AMD disease quiescence(at date of study visit and 6 months prior history)
- genotypic profile(date of study visit)