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

Phase 3

Completed

• Conditions: Non-Infectious Uveitis
• Interventions: Drug: FAI Insert administered using the Mk II inserter; Drug: FAI Insert administered using the Mk I inserter

• Registration Number: NCT02748512
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2016-02-23
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Primary Completion: 2017-08-17
• Study Completion: 2017-08-17
• Results First Submitted: 2020-01-29
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAI Insert administered using the Mk II inserter	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.
FAI Insert administered using the Mk I inserter	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.

Primary Outcome Measures

Name	Time	Method
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.	Day 7	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Charleston Neuroscience Institute; 🇺🇸 Ladson, South Carolina, United States

Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation; 🇺🇸 Waltham, Massachusetts, United States

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Foundation Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

Retina Consultants of Southern Colorado, PC; 🇺🇸 Colorado Springs, Colorado, United States

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States