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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02748512
Other study ID # PSV-FAI-006
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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