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Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

NCT02746991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-07-21

Study results available
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Summary

Phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.

Conditions

  • Posterior Uveitis
  • Intermediate Uveitis
  • Panuveitis

Interventions

DRUG

Sham Injection

Placebo

DRUG

FAI Insert

Fluocinolone Acetonide

Sponsors & Collaborators

  • EyePoint Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Flavio Leonin Jr., MD · EyePoint Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-02
Primary Completion
2019-10-04
Completion
2019-10-04

Countries

  • India

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 NCT02746991 on ClinicalTrials.gov