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|
|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).
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): NCT01482195
|Contact: Fowzan S Alkuraya, MD||+966 1 442 firstname.lastname@example.org|
|King Khaled Eye Specialist Hospital||Recruiting|
|Riyadh, Saudi Arabia, 11462|
|Contact: Deepak Edward, MD 96614821234 ext 1362 email@example.com|
|Principal Investigator: Emad Abboud, MD|
|Principal Investigator:||Fowzan S Alkuraya, MD||King Faisal Specialist Hospital & Research Center|