Seven Year Update of Macular Degeneration Patients (SEVEN UP)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Age-related Macular Degeneration

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01256827

IST-72116

FVF 4938s (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 1 patient group

ranibizumab in MARINA/ANCHOR

Description:

Exudative AMD patients previously enrolled in the ranibizumab treatment arms of the MARINA or ANCHOR studies with subsequent enrollment into the HORIZON extension study.