Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

NCT ID: NCT02746991

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-02
• Study Completion Date: 2019-10-04

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.

Detailed Description

This is a 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.

Conditions

Posterior Uveitis; Intermediate Uveitis; Panuveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Injection

Sham Injection

Group Type: SHAM_COMPARATOR

Sham Injection

Intervention Type: DRUG

Placebo

FAI Insert

FAI Insert (0.18 mg fluocinolone acetonide)

Group Type: EXPERIMENTAL

FAI Insert

Intervention Type: DRUG

Fluocinolone Acetonide

Interventions

Sham Injection

Placebo

Intervention Type: DRUG

FAI Insert

Fluocinolone Acetonide

Intervention Type: DRUG

Other Intervention Names

Placebo; Fluocinolone Acetonide

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Ocular surgery on the study eye within 3 months prior to study Day 1
• Capsulotomy in study eye within 30 days prior to study Day 1
• Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
• Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
• Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
• Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
• Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
• Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
• Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis
• Systemic infection within 30 days prior to study Day 1
• Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
• Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
• Treatment with an investigational drug or device within 30 days prior to study Day 1
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit
• Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flavio Leonin Jr., MD

Role: STUDY_DIRECTOR

EyePoint Pharmaceuticals, Inc.

Locations

LV. Prasad Eye Institute

Hyderabad, Andhra Pradesh, India

Sri Sankaradeva Nethralaya, Guwahati

Guwahati, Assam, India

Regional Institute of Opthalmology

Patna, Bihar, India

C.H. Nagri Municipal Eye Hospital

Ahmedabad, Gujarat, India

Seth G.S. Medical College & K.E.M Hospital

Mumbai, Maharashtra, India

Deenanath Mangeshkar Hospital, Pune

Pune, Maharashtra, India

PBMA'S, H. V. Desai Eye Hospital

Pune, Maharashtra, India

Dr. Shroff's Charity Eye Hospital

Daryāganj, New Delhi, India

Sankara Nethralaya hospital

Chennai, Tamil Nadu, India

Vasan Eye Care Hospital

Chennai, Tamil Nadu, India

Sri Ramachandra Hospital

Chennai, Tamil Nadu, India

J L Rohatgi Memorial Eye Hospital

Kanpur, Uttar Pradesh, India

King George's Medical University

Lucknow, Uttar Pradesh, India

ICARE Eye Hospital and Research centre

Noida, Uttar Pradesh, India

Regional Institute of Ophthalmology

Kolkata, West Bengal, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 38027419 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PSV-FAI-005

Identifier Type: -

Identifier Source: org_study_id