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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014