Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02357342
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2015-02-02
Brief Title:
Sirolimus Versus Anti-Vascular Endothelial Growth Factor antiVEGF for Wet AMD
Sponsor:
Maturi Raj K MD PC
Organization:
Maturi Raj K MD PC
Study Overview
Official Title:
Sirolimus Versus AntiVEGF for Wet AMD
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Phase 2 clinical trial single site randomized subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration wet AMD with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment
Detailed Description:
Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 11 ratio Over the course of the six month trial plus a 6 month optional extension subjects will be evaluated monthly Treatment with Sirolimus will be given at baseline month 2 and month 4 with sham injections given at months 1 3 and 5 For subjects in the extension Sirolimus will also be given at months 6 8 and 10 with sham at month 7 9 and 11 Subjects in the standard of care group will receive anti-VEGF injections or sham monthly Retreatment criteria will be based upon continued subretinal edema intraretinal edema or active chorioretinal neovascularization CNV
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