NCT01256827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

December 7, 2010

Last Update Submit

November 12, 2013

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degenerationranibizumabgeographic atrophyANCHOR StudyMARINA Study

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • mean change in visual acuity

    at study visit

  • visual acuity 20/200 or worse

    at date of study visit

  • visual acuity 20/40 or better

    at date of study visit

  • exudative AMD disease quiescence

    at date of study visit and 6 months prior history

  • central geographic atrophy

    date of study visit

  • +1 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Retina-Vitreous Associates

Beverly Hills, California, 90211, United States

Location

USC Keck School of Medicine, Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Midwest Eye institute

Indianapolis, Indiana, 46290, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, 28210, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples will be drawn

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Robert B. Bhisitkul, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 9, 2010

Study Start

December 1, 2010

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

US(12)