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Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

NCT01694186 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2021-04-02

Study results available
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Summary

A study to evaluate the safety and efficacy of an FAI insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye.

Conditions

  • Non-Infectious Uveitis

Interventions

DRUG

FAI insert

DRUG

Sham injection

Sponsors & Collaborators

  • EyePoint Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Glenn Jaffe, MD · Duke University Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-02
Primary Completion
2018-03-26
Completion
2018-03-26
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Hungary
  • India
  • Israel
  • United Kingdom

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 NCT01694186 on ClinicalTrials.gov