SEVEN UP: Seven Year Update of Macular Degeneration Patients

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01256827

Collaborator

Genentech, Inc. (Industry)

Enrollment

Locations

Duration (Months)

5.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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 :

Dec 1, 2010

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

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

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 20/200 or worse [at date of study visit]
% of study eyes with ETDRS best-corrected visual acuity 20/200 or worse
visual acuity 20/40 or better [at date of study visit]
% of study eyes with ETDRS best-corrected visual acuity 20/40 or better
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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina-Vitreous Associates	Beverly Hills	California	United States	90211
2	USC Keck School of Medicine, Doheny Eye Institute	Los Angeles	California	United States	90033
3	Northern California Retina Vitreous Associates	Mountain View	California	United States	94040
4	University of California San Francisco	San Francisco	California	United States	94143
5	Midwest Eye institute	Indianapolis	Indiana	United States	46290
6	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
7	Charlotte Eye, Ear, Nose & Throat Associates	Charlotte	North Carolina	United States	28210
8	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
9	Tennessee Retina	Nashville	Tennessee	United States	37203
10	Retina Research Center	Austin	Texas	United States	78705
11	Retina Consultants of Houston	Houston	Texas	United States	77030
12	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