Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

NCT01694186 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PSV-FAI-001
• Study Type: interventional
• Target: 129
• Locations: 6 countries
• Sites: 34

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.

Conditions

Non-Infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  36 months

Study Arms (2)

sham injection

SHAM COMPARATOR

sham injection

Drug: Sham injection

FAI insert

EXPERIMENTAL

FAI insert (0.18 mg fluocinolone acetonide)

Drug: FAI insert

Interventions

FAI insert DRUG

Also known as: Active Drug

FAI insert

Sham injection DRUG

Also known as: Sham Comparator

sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female at least 18 years of age at time of consent
• One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \> 1 year duration.
• During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
• systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
• at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis
• OR the study eye has experienced recurrence:
• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
• At the time of enrollment (Day 1), study eye has \< 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
• Visual acuity of study eye is at least 15 letters on the ETDRS chart
• Subject is not planning to undergo elective ocular surgery during the study
• Subject has ability to understand and sign the Informed Consent Form
• Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• Allergy to fluocinolone acetonide or any component of the FAI insert
• History of posterior uveitis only that is not accompanied by vitritis or macular edema
• History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
• Uveitis with infectious etiology
• Vitreous hemorrhage
• Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
• Ocular malignancy in either eye, including choroidal melanoma
• Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
• Previous viral retinitis
• Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure
• Media opacity precluding evaluation of retina and vitreous
• Peripheral retinal detachment in area of insertion
• Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg)
• Intraocular pressure (IOP) \> 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
• Chronic hypotony (\< 6 mmHg)

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (34)

Retina Vitreaous Associates

Beverly Hills, California, 90211, United States

Location

Retinal Consultants Medical Group, Inc

Sacramento, California, 95819, United States

Location

Retina Macula Institute

Torrance, California, 90503, United States

Location

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Ophthalmology & Visual Sciences

Lexington, Kentucky, 40508, United States

Location

Ocular Immunology and Uveitis Foundation

Cambridge, Massachusetts, 02142, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Retina Consultants

Slingerlands, New York, 12159, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

OHSU Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Foresight Studies, LLC

San Antonio, Texas, 78240, United States

Location

Augenarzte am St. Franziskus Hospital

Münster, Germany

Location

Universitatsklinikum Tubingen

Tübingen, Germany

Location

Bajcsy-Zsilinszky Kórház és Rendelőintézet

Budapest, Hungary

Location

L. V. Prasad Eye Institute - Hospital

Hyderabad, Andhra Pradesh, India

Location

L.V. Prasad Eye Institute

Pātia, Bhubaneshwar, India

Location

C.H Nagri Municipal Eye Hospital

Ahmedabad, Gujarat, India

Location

Seth G.S. Medical College & KEM Hospital

Pārel, Mumbai, India

Location

PBMA'S H.V. Desai Eye Hospital

Hadapsar, Pune, India

Location

King George's Medical University

Lucknow, Uttar Pradesh, India

Location

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Qiryat Ono, Israel

Location

Royal Hospitals Trust

Belfast, United Kingdom

Location

Birmingham and Midland Eye Centre

Birmingham, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Location

Moorfields Eye Hospital

London, United Kingdom

Location

St Thomas Hospital

London, United Kingdom

Location

Related Publications (1)

• Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology. 2020 Oct;127(10):1395-1404. doi: 10.1016/j.ophtha.2020.04.001. Epub 2020 Apr 17.

  PMID: 32624244 DERIVED

MeSH Terms

Interventions

Bulk Drugs; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Affairs
• Organization: Eyepoint Pharmacueticals

fleonin@eyepointpharma.com

6179726204

Study Officials

• Glenn Jaffe, MD

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: August 2, 2013
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: April 2, 2021
• Results First Posted: March 23, 2020

Record last verified: 2021-03

Locations

IL (3); HU (1); DE (2); IN (6); US (16); GB (6)