Clinical Trial: Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multi-Center, Randomized, Single Masked Phase 2 Study of Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy Associated With Age-Related Macular De

Brief Summary:

This study will seek to enroll 50 persons who have central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to receive one of the following treatments in the study eye:

  1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or
  2. A sham treatment (subconjunctival injection of lidocaine) Participants with two (2) eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and no sham in the fellow eye.

The first injection will begin at Day 0, which may occur on the date of screening/enrollment or up to two weeks following screening/enrollment visit, and every month thereafter. The visit schedule is as follows:

  1. A clinical evaluation, including safety measures, will occur monthly.
  2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and 24 months after the first injection has occurred.
  3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24 months after the first injection has occurred.
  4. Fundus color photography and optical coherence tomography will occur at screening/enrollment and at 6, 12, 18 and 24 months after the first injection has occurred.

The primary goal is to evaluate whether the persons receiving the sirolimus injections show a slower worsening of geographic atrophy compared to the persons receiving the sham injections. A secondary goal is to evaluate t

Detailed Summary:
Sponsor: National Eye Institute (NEI)

Current Primary Outcome: Rate of change in area of geographic atrophy [ Time Frame: Every 6 months after enrollment for 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in best-corrected visual acuity [ Time Frame: Every 6 months after enrollment for 2 years ]

Original Secondary Outcome: Same as current

Information By: National Eye Institute (NEI)

Dates:
Date Received: August 28, 2012
Date Started: February 2012
Date Completion: February 2016
Last Updated: December 8, 2015
Last Verified: December 2015