Seven Year Update of Macular Degeneration Patients (SEVEN UP)

• ClinicalTrials.gov Identifier: NCT01256827
• Recruitment Status: Completed
• First Posted: December 9, 2010
• Last Update Posted: November 14, 2013
• Sponsor: University of California, San Francisco
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease
Age-related Macular Degeneration

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 Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)
• Study Start Date: December 2010
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: April 2013

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. mean change in visual acuity [ Time Frame: 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
2. visual acuity 20/200 or worse [ Time Frame: at date of study visit ]
   % of study eyes with ETDRS best-corrected visual acuity 20/200 or worse
3. visual acuity 20/40 or better [ Time Frame: at date of study visit ]
   % of study eyes with ETDRS best-corrected visual acuity 20/40 or better
4. exudative AMD disease quiescence [ Time Frame: 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.
5. central geographic atrophy [ Time Frame: 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
6. genotypic profile [ Time Frame: 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

Biospecimen Retention:   Samples With DNA

blood samples will be drawn

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Exudative AMD patients who were previously participants in ranibizumab treatment arms of the ANCHOR or MARINA studies, and who subsequently enrolled in the HORIZON extension study

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

Contacts and Locations

Locations

United States, California

Retina-Vitreous Associates

Beverly Hills, California, United States, 90211

USC Keck School of Medicine, Doheny Eye Institute

Los Angeles, California, United States, 90033

Northern California Retina Vitreous Associates

Mountain View, California, United States, 94040

University of California San Francisco

San Francisco, California, United States, 94143

United States, Indiana

Midwest Eye institute

Indianapolis, Indiana, United States, 46290

United States, Massachusetts

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States, 02114

United States, North Carolina

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, United States, 28210

United States, South Dakota

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States, 57701

United States, Tennessee

Tennessee Retina

Nashville, Tennessee, United States, 37203

United States, Texas

Retina Research Center

Austin, Texas, United States, 78705

Retina Consultants of Houston

Houston, Texas, United States, 77030

Medical Center Ophthalmology Associates

San Antonio, Texas, United States, 78240

Sponsors and Collaborators

University of California, San Francisco

Genentech, Inc.

Investigators

• Principal Investigator: Robert B. Bhisitkul, MD, PhD; University of California, San Francisco
• Study Director: David S. Boyer, MD; Retina-Vitreous Associates
• Study Director: SriniVas Sadda, MD; USC Keck School of Medicine, Doheny Eye Institute
• Study Director: Kang Zhang, MD, PhD; University of California San Diego, Shiley Eye Center

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01256827
• Other Study ID Numbers: IST-72116; FVF 4938s ( Other Identifier: Genentech, Inc. )
• First Posted: December 9, 2010
• Last Update Posted: November 14, 2013
• Last Verified: November 2013

Keywords provided by University of California, San Francisco:

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

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases