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ACTIVE NOT RECRUITING
NCT04918121
EARLY_PHASE1

A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery

Sponsor: Sanjay Asrani

View on ClinicalTrials.gov

Summary

This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery. The primary aim of this study is to assess the safety and efficacy (controlling intraocular pressure) of the Yutiq inserts to reduce post-operative scarring in surgical glaucoma patients. It is expected that post-operative week 12 onwards there will be a clinically and statistically significant lower IOP in the study eyes than eyes in a group undergoing the same surgery without the Yutiq insert. The estimated duration of the present study is 3 years.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2021-07-20

Completion Date

2027-06

Last Updated

2025-11-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Yutiq 0.18 MG Drug Implant

a sustained-release steroid insert (Yutiq)

Locations (1)

Duke Eye Center

Durham, North Carolina, United States