Seven Year Update of Macular Degeneration Patients

Age-related Macular Degeneration Clinical Trial

— SEVEN UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256827
• Other study ID #: IST-72116
• Secondary ID: FVF 4938s
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: November 12, 2013
• Start date: December 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United States	Retina Research Center	Austin	Texas
United States	Retina-Vitreous Associates	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Charlotte Eye, Ear, Nose & Throat Associates	Charlotte	North Carolina
United States	Retina Consultants of Houston	Houston	Texas
United States	Midwest Eye institute	Indianapolis	Indiana
United States	USC Keck School of Medicine, Doheny Eye Institute	Los Angeles	California
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina	Nashville	Tennessee
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity 20/70 or better	percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)	at date of study visit	No
Secondary	mean change in visual acuity	Mean change in ETDRS best-corrected vision in study eyes, relative to baseline, exit from MARINA or ANCHOR, and exit from HORIZON	at study visit	No
Secondary	visual acuity 20/200 or worse	% of study eyes with ETDRS best-corrected visual acuity 20/200 or worse	at date of study visit	No
Secondary	visual acuity 20/40 or better	% of study eyes with ETDRS best-corrected visual acuity 20/40 or better	at date of study visit	No
Secondary	exudative AMD disease quiescence	% 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.	at date of study visit and 6 months prior history	No
Secondary	central geographic atrophy	% 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	date of study visit	No
Secondary	genotypic profile	Genome-wide screening for high interest genes for associations with: geographic atrophy, disciform scar, current disease activity, therapeutic response to ranibizumab therapy	date of study visit	No