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Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)

This study has been completed.
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000167
First received: September 23, 1999
Last updated: March 23, 2010
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
 Procedure: Low-Intensity Laser Treatment
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:
  • Change in visual acuity (3-line loss) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Changes in contrast threshold and critical print size for reading [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1052
Study Start Date: May 1999
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1
Laser treatment
 Procedure: Low-Intensity Laser Treatment
Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000167

  Show 24 Study Locations
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Study Chair: Stuart L Fine, MD Scheie Eye Institute, The University of Pennsylvania School of Medicine
  More Information

Additional Information:
NEI Clinical Studies Database  This link exits the ClinicalTrials.gov site

No publications provided by National Eye Institute (NEI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Natalie Kurinij, NEI
ClinicalTrials.gov Identifier: NCT00000167     History of Changes
Other Study ID Numbers: NEI-70
Study First Received: September 23, 1999
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Eye Institute (NEI):
Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013