Clinical Trial: Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase I/II Controlled Dose-escalating Trial to Establish the Baseline Safety and Efficacy of a Single Subretinal Injection of rAAV.sFlt-1 Into Eyes of Patients With Exudative Age-related Macular Deg

Brief Summary: The study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two doses of rAAV.sFlt-1 or assigned to the control group.

Detailed Summary:

A new treatment for exudative age-related macular degeneration (wet AMD) is being investigated. The purpose of this Phase I/II clinical research study is to examine the baseline safety and efficacy of an experimental study drug to treat a complication of the disease which leads to vision loss. The name of the study drug is rAAV.sFlt-1.

This experimental study uses a non-pathogenic virus to express a therapeutic protein within the eye. The therapeutic diminishes the growth of abnormal blood vessels under the retina. The duration of effect is thought to be long-term (years) following a single administration.

The clinical research study will look at the baseline safety and efficacy of a single injection of rAAV.sFlt-1 injected directly into the eye.

Approximately forty (40) subjects will participate in Australia. The primary endpoint of the study is at one month, with extended follow up for 3 years.


Sponsor: Lions Eye Institute, Perth, Western Australia

Current Primary Outcome: No sign of unresolved ophthalmic complications, toxicity or systemic complications as measured by laboratory tests from 1 month post injection [ Time Frame: Primary endpoint at 1 month ]

  1. Ocular examination:

    • Ocular inflammation
    • Intraocular pressure
    • Visual acuity
    • Retinal bleeding
  2. Abnormal laboratory data


Original Primary Outcome: Same as current

Current Secondary Outcome: Maintenance or improvement of vision without the necessity of ranibizumab re-injections [ Time Frame: Up to 3 years ]

  1. Best-corrected visual acuity
  2. CNV lesion
  3. Foveal thickness


Original Secondary Outcome: Same as current

Information By: Lions Eye Institute, Perth, Western Australia

Dates:
Date Received: December 14, 2011
Date Started: December 2011
Date Completion: May 2017
Last Updated: April 9, 2014
Last Verified: September 2012