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Seven Year Update of Macular Degeneration Patients

NCT ID: NCT01256827

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Age-related Macular Degeneration

Keywords

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age-related macular degeneration ranibizumab geographic atrophy ANCHOR Study MARINA Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ranibizumab in MARINA/ANCHOR

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert B. Bhisitkul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

David S. Boyer, MD

Role: STUDY_DIRECTOR

Retina-Vitreous Associates

SriniVas Sadda, MD

Role: STUDY_DIRECTOR

USC Keck School of Medicine, Doheny Eye Institute

Kang Zhang, MD, PhD

Role: STUDY_DIRECTOR

University of California San Diego, Shiley Eye Center

Locations

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Retina-Vitreous Associates

Beverly Hills, California, United States

Site Status

USC Keck School of Medicine, Doheny Eye Institute

Los Angeles, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

Midwest Eye institute

Indianapolis, Indiana, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Tennessee Retina

Nashville, Tennessee, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Retina Consultants of Houston

Houston, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FVF 4938s

Identifier Type: OTHER

Identifier Source: secondary_id

IST-72116

Identifier Type: -

Identifier Source: org_study_id