Clinical trial NCT02746991: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posterior Uveitis
Intermediate Uveitis
Panuveitis
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months
timeFrame: 36 Months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: LV. Prasad Eye Institute
state: Andhra Pradesh
city: Guwahati
country: India
facility: Sri Sankaradeva Nethralaya, Guwahati
state: Assam
city: Patna
country: India
facility: Regional Institute of Opthalmology
state: Bihar
city: Ahmedabad
country: India
facility: C.H. Nagri Municipal Eye Hospital
state: Gujarat
city: Mumbai
country: India
facility: Seth G.S. Medical College & K.E.M Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital, Pune
state: Maharashtra
city: Pune
country: India
facility: PBMA'S, H. V. Desai Eye Hospital
state: Maharashtra
city: Daryaganj
country: India
facility: Dr. Shroff's Charity Eye Hospital
state: New Delhi
city: Chennai
country: India
facility: Sankara Nethralaya hospital
state: Tamil Nadu
city: Chennai
country: India
facility: Vasan Eye Care Hospital
state: Tamil Nadu
city: Chennai
country: India
facility: Sri Ramachandra Hospital
state: Tamil Nadu
city: Kanpur
country: India
facility: J L Rohatgi Memorial Eye Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Noida
country: India
facility: ICARE Eye Hospital and Research centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: Regional Institute of Ophthalmology
state: West Bengal
Study officials:
affiliation: EyePoint Pharmaceuticals, Inc.
name: Flavio Leonin Jr., MD
role: STUDY_DIRECTOR
References: