Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert
Completed · Phase 3 · Has a placebo group
Conditions studied: Non-Infectious Uveitis
In brief
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.
Key facts
- Study ID
- NCT01694186
- Run by
- EyePoint Pharmaceuticals, Inc.
- People needed
- 129
- Starts
- 2013-08-02
- Expected to finish
- 2018-03-26
- Last updated by the study team
- 2021-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
- 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
Where it is running
- Retina Vitreaous Associates — Beverly Hills, California, United States
- Retinal Consultants Medical Group, Inc — Sacramento, California, United States
- Retina Macula Institute — Torrance, California, United States
- Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States
- Northwestern University — Chicago, Illinois, United States
- Ophthalmology & Visual Sciences — Lexington, Kentucky, United States
- Ocular Immunology and Uveitis Foundation — Cambridge, Massachusetts, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Retina Consultants — Slingerlands, New York, United States
- Duke University Eye Center — Durham, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- OHSU Casey Eye Institute — Portland, Oregon, United States
- Charleston Neuroscience Institute — Ladson, South Carolina, United States
- Texas Retina Associates — Arlington, Texas, United States
- Retina Consultants of Houston — Houston, Texas, United States
- Foresight Studies, LLC — San Antonio, Texas, United States
- Augenarzte am St. Franziskus Hospital — Münster, Germany
- Universitatsklinikum Tubingen — Tübingen, Germany
- Bajcsy-Zsilinszky Kórház és Rendelőintézet — Budapest, Hungary
- L. V. Prasad Eye Institute - Hospital — Hyderabad, Andhra Pradesh, India
- L.V. Prasad Eye Institute — Patia, Bhubaneshwar, India
- C.H Nagri Municipal Eye Hospital — Ahmedabad, Gujarat, India
- Seth G.S. Medical College & KEM Hospital — Pārel, Mumbai, India
- PBMA'S H.V. Desai Eye Hospital — Hadapsar, Pune, India
- King George's Medical University — Lucknow, Uttar Pradesh, India
Full record on ClinicalTrials.gov
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