Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration (AMD)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|