Complications of Age-Related Macular Degeneration Prevention Trial - Full Text View

Sponsor:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00000167

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 III

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

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.

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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

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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):

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. Print 2011 Nov.

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 February 12, 2012