Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
1 other identifier
interventional
153
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2015
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2015
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2019
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 21, 2020
July 1, 2020
4.3 years
April 19, 2016
June 17, 2020
July 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)
6 Months
Secondary Outcomes (1)
Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months
36 Months
Study Arms (2)
Sham Injection
SHAM COMPARATORSham Injection
FAI Insert
EXPERIMENTALFAI Insert (0.18 mg fluocinolone acetonide)
Interventions
Eligibility Criteria
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
- At the time of enrollment (Day 1), study eye has \< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.
- Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (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
- 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 administrations 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
You may not qualify if:
- Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (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 structures
- 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 Intraocular pressure (IOP) in the normal range (10-21 mmHg)
- IOP \> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye
- Chronic hypotony (\< 6 mmHg)
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
LV. Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500034, India
Sri Sankaradeva Nethralaya, Guwahati
Guwahati, Assam, 781028, India
Regional Institute of Opthalmology
Patna, Bihar, 800014, India
C.H. Nagri Municipal Eye Hospital
Ahmedabad, Gujarat, 380006, India
Seth G.S. Medical College & K.E.M Hospital
Mumbai, Maharashtra, 400012, India
Deenanath Mangeshkar Hospital, Pune
Pune, Maharashtra, 411004, India
PBMA'S, H. V. Desai Eye Hospital
Pune, Maharashtra, 411060, India
Dr. Shroff's Charity Eye Hospital
Daryāganj, New Delhi, 110002, India
Sankara Nethralaya hospital
Chennai, Tamil Nadu, 600006, India
Vasan Eye Care Hospital
Chennai, Tamil Nadu, 600015, India
Sri Ramachandra Hospital
Chennai, Tamil Nadu, 600116, India
J L Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, 208005, India
King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
ICARE Eye Hospital and Research centre
Noida, Uttar Pradesh, 201301, India
Regional Institute of Ophthalmology
Kolkata, West Bengal, 700073, India
Related Publications (1)
Biswas J, Tyagi M, Agarwal M; PSV-FAI-005 Investigation Group. The 0.2-mug/day Fluocinolone Acetonide Intravitreal Implant in Chronic Noninfectious Posterior Uveitis: A 3-year Randomized Trial in India. Ophthalmol Sci. 2023 Sep 16;4(1):100403. doi: 10.1016/j.xops.2023.100403. eCollection 2024 Jan-Feb.
PMID: 38027419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Flavio Leonin Jr., MD
- Organization
- EyePoint Pharmaceutical
Study Officials
- STUDY DIRECTOR
Flavio Leonin Jr., MD
EyePoint Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
April 19, 2016
First Posted
April 21, 2016
Study Start
June 2, 2015
Primary Completion
October 4, 2019
Study Completion
October 4, 2019
Last Updated
July 21, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-07