Seven Year Update of Macular Degeneration Patients (SEVEN UP)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01256827
First received: December 7, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
Age-related Macular Degeneration

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • visual acuity 20/70 or better [ Time Frame: at date of study visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: at study visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: at date of study visit ] [ Designated as safety issue: No ]
    % of study eyes with ETDRS best-corrected visual acuity 20/200 or worse

  • visual acuity 20/40 or better [ Time Frame: at date of study visit ] [ Designated as safety issue: No ]
    % of study eyes with ETDRS best-corrected visual acuity 20/40 or better

  • exudative AMD disease quiescence [ Time Frame: at date of study visit and 6 months prior history ] [ Designated as safety issue: No ]
    % 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 [ Time Frame: date of study visit ] [ Designated as safety issue: No ]
    % 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 [ Time Frame: date of study visit ] [ Designated as safety issue: No ]
    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


Enrollment: 65
Study Start Date: December 2010
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256827

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
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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01256827     History of Changes
Other Study ID Numbers: IST-72116, FVF 4938s
Study First Received: December 7, 2010
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014