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

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ClinicalTrials.gov Identifier: NCT02746991
Recruitment Status : Completed
First Posted : April 21, 2016
Results First Posted : July 7, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
EyePoint Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Posterior Uveitis Intermediate Uveitis Panuveitis Drug: Sham Injection Drug: FAI Insert Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2, 2015
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham Injection
Sham Injection
 Drug: Sham Injection
Placebo
Other Name: Placebo
Experimental: FAI Insert
FAI Insert (0.18 mg fluocinolone acetonide)
 Drug: FAI Insert
Fluocinolone Acetonide
Other Name: Fluocinolone Acetonide


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months [ Time Frame: 6 Months ]
    Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)


Secondary Outcome Measures :
  1. Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months [ Time Frame: 36 Months ]
    Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746991


Locations
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India
LV. Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500034
Sri Sankaradeva Nethralaya, Guwahati
Guwahati, Assam, India, 781028
Regional Institute of Opthalmology
Patna, Bihar, India, 800014
C.H. Nagri Municipal Eye Hospital
Ahmedabad, Gujarat, India, 380006
Seth G.S. Medical College & K.E.M Hospital
Mumbai, Maharashtra, India, 400012
Deenanath Mangeshkar Hospital, Pune
Pune, Maharashtra, India, 411004
PBMA'S, H. V. Desai Eye Hospital
Pune, Maharashtra, India, 411060
Dr. Shroff's Charity Eye Hospital
Daryaganj, New Delhi, India, 110002
Sankara Nethralaya hospital
Chennai, Tamil Nadu, India, 600006
Vasan Eye Care Hospital
Chennai, Tamil Nadu, India, 600015
Sri Ramachandra Hospital
Chennai, Tamil Nadu, India, 600116
J L Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, India, 208005
King George's Medical University
Lucknow, Uttar Pradesh, India, 226003
ICARE Eye Hospital and Research centre
Noida, Uttar Pradesh, India, 201301
Regional Institute of Ophthalmology
Kolkata, West Bengal, India, 700073
Sponsors and Collaborators
EyePoint Pharmaceuticals, Inc.
Investigators
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Study Director: Flavio Leonin Jr., MD EyePoint Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by EyePoint Pharmaceuticals, Inc.:
Study Protocol  [PDF] March 10, 2017
Statistical Analysis Plan  [PDF] March 10, 2017

More Information
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Responsible Party: EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02746991    
Other Study ID Numbers: PSV-FAI-005
First Posted: April 21, 2016    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 21, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
 Choroid Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs