Utilization and Safety of the Mk II Inserter and the Safety of the FAI Insert in Non-Infectious Uveitis (MkII)

A Controlled, Multi-Center Study of the Utilization and Safety of the MkII Inserter and the Safety of the FAI Insert in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.

This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

Study Overview

• Status: Completed
• Conditions: Non-Infectious Uveitis
• Intervention / Treatment: Drug: FAI Insert administered using the Mk II inserter; Drug: FAI Insert administered using the Mk I inserter

Detailed Description

This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern Colorado, PC
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Eye Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation Cole Eye Institute
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Charleston Neuroscience Institute
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant female at least 18 years of age at time of consent
2. At least one eye has a history of non-infectious uveitis affecting the posterior segment
3. Subject has ability to understand and sign the Informed Consent Form
4. Subject is willing and able to comply with study requirements

Exclusion Criteria:

1. Allergy to fluocinolone acetonide or any component of the FAI insert
2. Ocular malignancy in either eye, including choroidal melanoma
3. Uveitis with infectious etiology
4. Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
5. Current mycobacterial infections of the eye or fungal diseases of ocular structures
6. Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
7. Systemic infection within 30 days prior to study Day 1
8. Peripheral retinal detachment in area of insertion
9. Elevated intraocular pressure (IOP) > 21 mmHg, or chronic hypotony < 6 mmHg
10. Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
11. Current 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)
12. Known history of clinically significant IOP elevation in response to steroid treatment in either eye, 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)
13. Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
14. Intravitreal treatment of study eye: with FAI insert within 36 months prior to study Day 1;with Retisert within 30 months prior to study Day 1; with Ozurdex within 90 days prior to study Day 1; or with Triesence or Trivaris within 30 days prior to study Day 1
15. Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1
16. Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol
17. 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
18. Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAI Insert administered using the Mk II inserter; The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.	Drug: FAI Insert administered using the Mk II inserter; Other Names: Fluocinolone Acetonide Intravitreal (FAI)
Active Comparator: FAI Insert administered using the Mk I inserter; The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.	Drug: FAI Insert administered using the Mk I inserter; Other Names: Fluocinolone Acetonide Intravitreal (FAI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.	The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.	To assess the safety of the FAI insert during 12 months following treatment reported as percentages.	Month 12

Collaborators and Investigators

• Sponsor: EyePoint Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Flavio Leonin Jr., MD, pSivida Corp, Senior Manager, Clinical Affairs; Study Chair: Gerard E Riedel, PhD, pSivida Corp, Vice President, Regulatory Affairs; Study Director: Paul Ashton, PhD, pSivida Corp, Chief Executive Officer

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2016
• Primary Completion (Actual): August 17, 2017
• Study Completion (Actual): August 17, 2017

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluocinolone Acetonide
• Other Study ID Numbers: PSV-FAI-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes