Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration (AMD)
|ClinicalTrials.gov Identifier: NCT01494805|
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : September 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration Age-related Maculopathies Age-related Maculopathy Maculopathies,Age-related Maculopathy,Age-related Retinal Degeneration Retinal Neovascularization Eye Diseases||Biological: rAAV.sFlt-1 Other: Control (ranibizumab alone)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Degeneration (AMD)|
|Actual Study Start Date :||December 2011|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||August 2017|
|Experimental: Low Dose rAAV.sFlt-1||
1 x 10^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
|Experimental: High Dose rAAV.sFlt-1||
1 x 10^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
|Active Comparator: Control - ranibizumab only||
Other: Control (ranibizumab alone)
Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).
- 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 inflammation
- Intraocular pressure
- Visual acuity
- Retinal bleeding
- Abnormal laboratory data
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494805
|Australia, Western Australia|
|Lions Eye Institute|
|Nedlands, Western Australia, Australia, 6009|
|Principal Investigator:||Ian Constable, Professor||Lions Eye Institute|