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Completed

NCT Number: NCT01256827

Seven Year Update of Macular Degeneration Patients

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina-Vitreous Associates, Beverly Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)

Acronym: SEVEN UP

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 9, 2010
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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