Clinical trial NCT01694186: Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
Official title: A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Infectious Uveitis
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 129
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: 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.

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.
* 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

Exclusion Criteria

* 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)
* 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 test positive for human immune deficiency virus (HIV) or syphilis during screening
* Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
* 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: 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
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina Vitreaous Associates
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
city: Torrance
country: United States
facility: Retina Macula Institute
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lexington
country: United States
facility: Ophthalmology & Visual Sciences
state: Kentucky
city: Cambridge
country: United States
facility: Ocular Immunology and Uveitis Foundation
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Slingerlands
country: United States
facility: Retina Consultants
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: OHSU Casey Eye Institute
state: Oregon
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Foresight Studies, LLC
state: Texas
city: Munster
country: Germany
facility: Augenarzte am St. Franziskus Hospital
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet
city: Hyderabad
country: India
facility: L. V. Prasad Eye Institute - Hospital
state: Andhra Pradesh
city: Patia
country: India
facility: L.V. Prasad Eye Institute
state: Bhubaneshwar
city: Ahmedabad
country: India
facility: C.H Nagri Municipal Eye Hospital
state: Gujarat
city: Parel
country: India
facility: Seth G.S. Medical College & KEM Hospital
state: Mumbai
city: Hadapsar
country: India
facility: PBMA'S H.V. Desai Eye Hospital
state: Pune
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Qiryat Ono
country: Israel
facility: Sheba Medical Center
city: Belfast
country: United Kingdom
facility: Royal Hospitals Trust
city: Birmingham
country: United Kingdom
facility: Birmingham and Midland Eye Centre
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
Study officials:
affiliation: Duke University Eye Center
name: Glenn Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.