Seven Year Update of Macular Degeneration Patients

Completed

• Conditions: Age-related Macular Degeneration

• Registration Number: NCT01256827
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-09
• Primary Completion: 2012-10
• Study Completion: 2013-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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Exclusion Criteria

• any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
visual acuity 20/70 or better	at date of study visit	percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)

Secondary Outcome Measures

Name	Time	Method
central geographic atrophy	date of study visit	% of patients: 1) with central geographic atrophy (GA); 2) demonstrating progression of GA compared to baseline, exit from MARINA/ANCHOR, and exit from HORIZON; 3) with fellow eye GA development. GA measured by: fundus autofluorescence, high resolution OCT, and by interval comparison of fundus photography and fluorescein angiography
mean change in visual acuity	at study visit	Mean change in ETDRS best-corrected vision in study eyes, relative to baseline, exit from MARINA or ANCHOR, and exit from HORIZON
visual acuity 20/40 or better	at date of study visit	% of study eyes with ETDRS best-corrected visual acuity 20/40 or better
visual acuity 20/200 or worse	at date of study visit	% of study eyes with ETDRS best-corrected visual acuity 20/200 or worse
exudative AMD disease quiescence	at date of study visit and 6 months prior history	% of eyes that have attained disease quiescence, defined by: 1) No leakage (SRF, PED, CME, CFT greater than 250 um on OCT) on clinical exam or on studies. 2) no subretinal intraretinal hemorrhage on clinical exam or FA, 3) Historical: none of the above in the last 6 months by chart review or history, and no treatment for exudative AMD within the last 6 months.
genotypic profile	date of study visit	Genome-wide screening for high interest genes for associations with: geographic atrophy, disciform scar, current disease activity, therapeutic response to ranibizumab therapy

Trial Locations

Locations (12)

USC Keck School of Medicine, Doheny Eye Institute; 🇺🇸 Los Angeles, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Midwest Eye institute; 🇺🇸 Indianapolis, Indiana, United States

Retina-Vitreous Associates; 🇺🇸 Beverly Hills, California, United States

Charlotte Eye, Ear, Nose & Throat Associates; 🇺🇸 Charlotte, North Carolina, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Retina Research Center; 🇺🇸 Austin, Texas, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

Tennessee Retina; 🇺🇸 Nashville, Tennessee, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States