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Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert

NCT05070728 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-19

Study results available
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Summary

A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.

Conditions

  • Uveitis
  • Uveitis, Posterior
  • Uveitis, Intermediate

Interventions

DRUG

Sham Injector

Intravitreal sham injection

DRUG

FAI Insert

Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks. Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.

Sponsors & Collaborators

  • EyePoint Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2023-04-12
Completion
2023-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070728 on ClinicalTrials.gov