Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01786395
Status:
TERMINATED
Last Update Posted:
2016-01-29
First Post:
2013-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Efficacy and Safety Clinical Study of UF-021 for Treatment of Retinitis Pigmentosa
Sponsor:
R-Tech Ueno, Ltd.
Organization:
Study Overview
Official Title:
Phase III Clinical Study of UF-021 for Retinitis Pigmentosa - Evaluation for a Comparative Double Masked Placebo Controlled Study Period and a Continuous Administration Period
Status:
TERMINATED
Status Verified Date:
2013-03
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 is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period.
Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa.
The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.
Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa.
The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: