Clinical trial NCT01256827: Seven Year Update of Macular Degeneration Patients
Official title: Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration
ranibizumab
geographic atrophy
ANCHOR Study
MARINA Study
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-12-09
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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 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

Primary outcomes:
measure: visual acuity 20/70 or better
timeFrame: at date of study visit
Secondary outcomes:
measure: mean change in visual acuity
timeFrame: at study visit
measure: visual acuity 20/200 or worse
timeFrame: at date of study visit
measure: visual acuity 20/40 or better
timeFrame: at date of study visit
measure: exudative AMD disease quiescence
timeFrame: at date of study visit and 6 months prior history
measure: central geographic atrophy
timeFrame: date of study visit
measure: genotypic profile
timeFrame: date of study visit
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine, Doheny Eye Institute
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Indianapolis
country: United States
facility: Midwest Eye institute
state: Indiana
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: University of California, San Francisco
name: Robert B. Bhisitkul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retina-Vitreous Associates
name: David S. Boyer, MD
role: STUDY_DIRECTOR
affiliation: USC Keck School of Medicine, Doheny Eye Institute
name: SriniVas Sadda, MD
role: STUDY_DIRECTOR
affiliation: University of California San Diego, Shiley Eye Center
name: Kang Zhang, MD, PhD
role: STUDY_DIRECTOR
References: