Trial of Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus (rAAV2-VMD2-hMERTK) Gene Vector to Patients With Retinal Disease Due to MERTK Mutations
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|ClinicalTrials.gov Identifier: NCT01482195|
Recruitment Status : Recruiting
First Posted : November 30, 2011
Last Update Posted : November 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Retinal Disease||Genetic: Recombinant Adeno-Associated Virus||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus (rAAV2-VMD2-hMERTK) Gene Vector to Patients With Retinal Disease Due to MERTK Mutations|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2023|
U.S. FDA Resources
|Experimental: Recombinant Adeno-Associated Virus||
Genetic: Recombinant Adeno-Associated Virus
Ocular Subretinal Injection of a Recombinant Adeno-Associated Virus
- Ocular and Systemic safety of uniocular subretinal administration of rAAV2-VMD2-hMERTK in individuals with MERTK-associated retinal disease [ Time Frame: 12 yrs ]
- Vitreous hemorrhage.
- Organs systemic toxicity.
- Antibody titers to AAV capsid components and Antigen-specific Reactivity (ASR) Measurement.
- Peripheral Blood PCR.
- Visual Outcome [ Time Frame: 12 yrs ]
- ETDRS visual acuity measurement.
- Full-field Stimulation Threshold (FST).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482195
|Contact: Fowzan S Alkuraya, MD||+966 1 442 email@example.com|
|King Khaled Eye Specialist Hospital||Recruiting|
|Riyadh, Saudi Arabia, 11462|
|Contact: Deepak Edward, MD 96614821234 ext 1362 firstname.lastname@example.org|
|Principal Investigator: Emad Abboud, MD|
|Principal Investigator:||Fowzan S Alkuraya, MD||King Faisal Specialist Hospital & Research Center|