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

Non-Infectious Uveitis Clinical Trial

— MkII  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748512
• Other study ID #: PSV-FAI-006
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: April 2020
• Source: EyePoint
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-Infectious Uveitis
• Uveitis

Intervention

Drug:
• FAI Insert administered using the Mk II inserter

• FAI Insert administered using the Mk I inserter

Locations

Country	Name	City	State
United States	Texas Retina Associates	Arlington	Texas
United States	Cleveland Clinic Foundation Cole Eye Institute	Cleveland	Ohio
United States	Retina Consultants of Southern Colorado, PC	Colorado Springs	Colorado
United States	Duke Eye Center	Durham	North Carolina
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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