Clinical Trial: Micropulse Laser for Geographic Atrophy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macula

Brief Summary: Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.

Detailed Summary:
Sponsor: Institut de la Macula y la Retina

Current Primary Outcome: Change in area of atrophy as measured with fundus autofluorescence [ Time Frame: Change in area from baseline to week 48 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institut de la Macula y la Retina

Dates:
Date Received: February 25, 2013
Date Started: August 2012
Date Completion: June 2017
Last Updated: March 23, 2015
Last Verified: March 2015