Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-15 @ 4:05 AM
Study NCT ID:
NCT02348359
Status:
TERMINATED
Last Update Posted:
2022-02-11
First Post:
2015-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
X-82 to Treat Age-related Macular Degeneration
Sponsor:
Tyrogenex
Organization:
Study Overview
Official Title:
A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis found study had achieved primary objective
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
Detailed Description:
Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:
* X-82 50 mg plus ivt anti-VEGF prn
* X-82 100 mg plus ivt anti-VEGF prn
* X-82 200 mg plus ivt anti-VEGF prn
* Placebo plus ivt anti-VEGF prn
Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.
Primary Efficacy Outcome:
The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.
Safety Outcomes:
Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
* X-82 50 mg plus ivt anti-VEGF prn
* X-82 100 mg plus ivt anti-VEGF prn
* X-82 200 mg plus ivt anti-VEGF prn
* Placebo plus ivt anti-VEGF prn
Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.
Primary Efficacy Outcome:
The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.
Safety Outcomes:
Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
Study Oversight
Has Oversight DMC:
True
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?: