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Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis

NCT02748512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-05-01

Study results available
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Summary

This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Conditions

  • Non-Infectious Uveitis

Interventions

DRUG

FAI Insert administered using the Mk II inserter

DRUG

FAI Insert administered using the Mk I inserter

Sponsors & Collaborators

  • EyePoint Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Flavio Leonin Jr., MD · pSivida Corp, Senior Manager, Clinical Affairs

  • Gerard E Riedel, PhD · pSivida Corp, Vice President, Regulatory Affairs

  • Paul Ashton, PhD · pSivida Corp, Chief Executive Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-23
Primary Completion
2017-08-17
Completion
2017-08-17
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 NCT02748512 on ClinicalTrials.gov