Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01482195
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2011-09-28
Brief Title:
Trial of Subretinal Injection of rAAV2-VMD2-hMERTK
Sponsor:
King Khaled Eye Specialist Hospital
Organization:
King Khaled Eye Specialist Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was to assess the safety of gene transfer via subretinal administration of rAAV2-VMD2-hMERTK in subjects with MERTK-associated retinitis pigmentosa RP
Detailed Description:
In this phase I open-label dose-escalation trial one eye of each patient the worse-seeing eye in five subjects will receive a submacular injection of the subretinal rAAV2-VMD2-hMERTK Patients will be followed daily for 10 days and then at 30 60 90 180 270 365 540 and 730 days post-injection Data will be collected on 1 full ophthalmologic examination including best-corrected VA intraocular pressure color fundus photographs macular spectral-domain optical coherence tomography and full-field stimulus threshold test FST in both the study and fellow eyes 2 systemic safety data including CBC liver and kidney function tests coagulation profiles urine analysis AAV antibody titers peripheral blood PCR and ASR measurement and 3 listing of ophthalmological or systemic adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None