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

NCT02748512 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PSV-FAI-006
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-Infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.

  Month 12

Study Arms (2)

FAI Insert administered using the Mk II inserter

EXPERIMENTAL

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

FAI Insert administered using the Mk I inserter

ACTIVE COMPARATOR

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

Interventions

FAI Insert administered using the Mk II inserter DRUG

Also known as: Fluocinolone Acetonide Intravitreal (FAI)

FAI Insert administered using the Mk II inserter

FAI Insert administered using the Mk I inserter DRUG

Also known as: Fluocinolone Acetonide Intravitreal (FAI)

FAI Insert administered using the Mk I inserter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy to fluocinolone acetonide or any component of the FAI insert
• Ocular malignancy in either eye, including choroidal melanoma
• Uveitis with infectious etiology
• Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
• Current mycobacterial infections of the eye or fungal diseases of ocular structures
• Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis
• Systemic infection within 30 days prior to study Day 1
• Peripheral retinal detachment in area of insertion
• Elevated intraocular pressure (IOP) \> 21 mmHg, or chronic hypotony \< 6 mmHg
• Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye
• 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)
• 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)
• Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1
• 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
• Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (6)

Retina Consultants of Southern Colorado, PC

Colorado Springs, Colorado, 80909, United States

Location

Massachusetts Eye Research and Surgery Institution / Ocular Immunology & Uveitis Foundation

Waltham, Massachusetts, 02451, United States

Location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Kelley Collins-Winters, RTR, BS, MBA
• Organization: Axiom

kelleyc@axiom.cc

469-667-6655

Study Officials

• Flavio Leonin Jr., MD

  pSivida Corp, Senior Manager, Clinical Affairs

  PRINCIPAL INVESTIGATOR

• Gerard E Riedel, PhD

  pSivida Corp, Vice President, Regulatory Affairs

  STUDY CHAIR

• Paul Ashton, PhD

  pSivida Corp, Chief Executive Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 22, 2016
• Study Start: February 23, 2016
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Locations

US (6)