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 ]
Ocular examination:
- Ocular inflammation
- Intraocular pressure
- Visual acuity
- Retinal bleeding
- 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 ]
- Best-corrected visual acuity
- CNV lesion
- 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