Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

Phase 3

Completed

• Conditions: Non-Infectious Uveitis
• Interventions: Drug: Sham injection; Drug: FAI insert

• Registration Number: NCT01694186
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief 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.

Detailed Description

This is a phase 3, multi-national, 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 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.

Study Timeline

• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-27
• Study Start: 2013-08-02
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Results First Submitted: 2019-03-25
• Results First Submitted QC: 2020-03-04
• Results First Posted: 2020-03-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham injection	Sham injection	sham injection
FAI insert	FAI insert	FAI insert (0.18 mg fluocinolone acetonide)

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit	36 months	Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.

Trial Locations

Locations (34)

PBMA'S H.V. Desai Eye Hospital; 🇮🇳 Hadapsar, Pune, India

Retina Macula Institute; 🇺🇸 Torrance, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Charleston Neuroscience Institute; 🇺🇸 Ladson, South Carolina, United States

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

Retina Consultants of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Sheba Medical Center; 🇮🇱 Qiryat Ono, Israel

King George's Medical University; 🇮🇳 Lucknow, Uttar Pradesh, India

Bajcsy-Zsilinszky Kórház és Rendelőintézet; 🇭🇺 Budapest, Hungary

Seth G.S. Medical College & KEM Hospital; 🇮🇳 Parel, Mumbai, India

OHSU Casey Eye Institute; 🇺🇸 Portland, Oregon, United States

Ocular Immunology and Uveitis Foundation; 🇺🇸 Cambridge, Massachusetts, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

L. V. Prasad Eye Institute - Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

L.V. Prasad Eye Institute; 🇮🇳 Patia, Bhubaneshwar, India

Hadassah University Hospital Ein Kerem; 🇮🇱 Jerusalem, Israel

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, United Kingdom

Duke University Eye Center; 🇺🇸 Durham, North Carolina, United States

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

St Thomas Hospital; 🇬🇧 London, United Kingdom

Augenarzte am St. Franziskus Hospital; 🇩🇪 Munster, Germany

Retina Vitreaous Associates; 🇺🇸 Beverly Hills, California, United States

Retinal Consultants Medical Group, Inc; 🇺🇸 Sacramento, California, United States

Ophthalmology & Visual Sciences; 🇺🇸 Lexington, Kentucky, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Retina Consultants; 🇺🇸 Slingerlands, New York, United States

Foresight Studies, LLC; 🇺🇸 San Antonio, Texas, United States

Universitatsklinikum Tubingen; 🇩🇪 Tubingen, Germany

C.H Nagri Municipal Eye Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Royal Hospitals Trust; 🇬🇧 Belfast, United Kingdom

Birmingham and Midland Eye Centre; 🇬🇧 Birmingham, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom