Clinical Trial: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

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

Official Title: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

Brief Summary: This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.

Detailed Summary:
Sponsor: Stanford University

Current Primary Outcome: Change in macular drusen volume [ Time Frame: 12 and 24 months ]

Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)


Original Primary Outcome: Change in macular drusen volume [ Time Frame: 12 and 24 months ]

Mean change in macular drusen volume as measured on high-resolution SD-OCT


Current Secondary Outcome:

  • Change in visual acuity [ Time Frame: 12 and 24 months ]
    Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart
  • Development of geographic atrophy (GA) or choroidal neovascularization (CNV) [ Time Frame: 2 years ]
    Percentage of subjects who develop geographic atrophy or choroidal neovascularization by 24 months.


Original Secondary Outcome:

  • Change in visual acuity [ Time Frame: 12 and 24 months ]
    Mean change in best-corrected visual acuity as measured using ETDRS chart
  • Development of GA or CNV [ Time Frame: 2 years ]
    Percentage of subjects who develop geographic atrophy or choroidal neovascularization by 24 months.


Information By: Stanford University

Dates:
Date Received: October 5, 2015
Date Started: September 2015
Date Completion: December 2018
Last Updated: October 12, 2016
Last Verified: October 2016