NCT00000167

Brief Summary

To determine whether application of low-intensity laser treatment of eyes with drusen in the macula can prevent later complications of age-related macular degeneration and thereby preserve visual function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,052

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1999

Longer than P75 for phase_3

Geographic Reach
1 country

24 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

May 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 24, 2010

Status Verified

December 1, 2007

First QC Date

September 23, 1999

Last Update Submit

March 23, 2010

Conditions

Macular Degeneration

Keywords

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change in visual acuity (3-line loss)

    5 years

Secondary Outcomes (2)

  • Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy

    5 years

  • Changes in contrast threshold and critical print size for reading

    5 years

Study Arms (1)

1

EXPERIMENTAL

Laser treatment

Procedure: Low-Intensity Laser Treatment

Interventions

Low-Intensity Laser TreatmentPROCEDURE

Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients eligible for CAPT can be either male or female and meet the following criteria: Age at least 50 years old Vision in each eye must measure 20/40 or better. At least 10 large drusen in each eye Available for follow-up examinations for 5 years after enrollment Final eligibility is determined through a detailed eye examination by a CAPT-certified ophthalmologist.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (24)

Retinal Consultants of Arizona, Ltd.

Mesa, Arizona, 85201, United States

Location

Retinal Consultants of Arizona, Ltd.

Peoria, Arizona, 85351, United States

Location

West Coast Retina Medical Group, Inc.

San Francisco, California, 94107, United States

Location

University of South Florida Eye Institute

Tampa, Florida, 33612-4766, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Illinois Retina Associates, S.C.

Harvey, Illinois, 60426, United States

Location

University of Iowa

Iowa City, Iowa, 55242-1091, United States

Location

Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine

Louisville, Kentucky, 40202-1594, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287-9223, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Associate Retinal Consultants, P.C.

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

Retina-Vitreous Center, P.A.

Edison, New Jersey, 08820, United States

Location

Retina-Vitreous Center, P.A.

Lakewood, New Jersey, 08701, United States

Location

Southeast Clinical Research Associates

Charlotte, North Carolina, 28204, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44122, United States

Location

The Ohio State University, Department of Ophthalmology

Columbus, Ohio, 43210, United States

Location

Casey Eye Institute

Portland, Oregon, 97201-4197, United States

Location

Retina Northwest, P.C.

Portland, Oregon, 97210, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • Brader HS, Ying GS, Martin ER, Maguire MG; Complications of Age-Related Macular Degeneration Prevention Trial-CAPT Research Group. New grading criteria allow for earlier detection of geographic atrophy in clinical trials. Invest Ophthalmol Vis Sci. 2011 Nov 29;52(12):9218-25. doi: 10.1167/iovs.11-7493.

    PMID: 22039251DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Stuart L Fine, MD

    Scheie Eye Institute, The University of Pennsylvania School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

May 1, 1999

Study Completion

June 1, 2006

Last Updated

March 24, 2010

Record last verified: 2007-12

Locations

US(24)