Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT05761795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of IVMED-85 on Pediatric Myopia
Sponsor:
iVeena Delivery Systems, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.
The main question\[s\] it aims to answer are:
* Does IVMED 85 improve visual acuity
* Does IVMED 85 slow or otherwise change the progression of myopia
Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
The main question\[s\] it aims to answer are:
* Does IVMED 85 improve visual acuity
* Does IVMED 85 slow or otherwise change the progression of myopia
Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: