Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert

NCT05070728 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: EYP-2102-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Intermediate

Keywords

EYP-2102; EyePoint; Uveitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24

  Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.

  Week 24

Secondary Outcomes (8)

• Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52

  Week 52

• Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52

  Weeks 24 and 52

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52

  Weeks 24 and 52

• Number of Recurrences of Uveitis Within 24 and 52 Weeks

  Weeks 24 and 52

• Time to Recurrence of Uveitis Through Weeks 24 and 52

  Weeks 24 and 52

Study Arms (2)

Sham Comparator

SHAM COMPARATOR

Intravitreal sham injection

Drug: Sham Injector

FAI insert (0.05 mg fluocinolone acetonide)

ACTIVE COMPARATOR

Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg).

Drug: FAI Insert

Interventions

Sham Injector DRUG

Intravitreal sham injection

Also known as: Sham Comparator

Sham Comparator

FAI Insert DRUG

Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks. Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.

Also known as: Active Drug

FAI insert (0.05 mg fluocinolone acetonide)

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.
• One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis \>1 year duration.
• During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
• Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR
• at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR
• the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
• At the time of enrollment (Day 1), the study eye has \<10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade 2.
• Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
• Not planning to undergo elective ocular surgery during the study.
• Able to understand and sign the Informed Consent Form (ICF).
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• History of posterior uveitis only that is not accompanied by vitritis or macular edema.
• History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1.
• Uveitis with infectious etiology.
• Vitreous hemorrhage.
• Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
• Uveitis limited to the anterior segment, ie, anterior uveitis only.
• Ocular malignancy in either eye, including choroidal melanoma.
• Previous viral retinitis.
• Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.
• Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye, or fungal diseases of ocular structures.
• Media opacity precluding evaluation of retina and vitreous.
• Peripheral retinal detachment in area of insertion.
• Diagnosis of any form of glaucoma or ocular hypertension at Screening, unless previously treated with an incisional surgery procedure that has resulted in stable intraocular pressure (IOP) in the normal range \[10-21 millimeter of mercury (mmHg)\].
• IOP \>21 mmHg or concurrent therapy at Screening with any IOP lowering pharmacologic agent.
• Chronic hypotony (\<6 mmHg).

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (1)

EyePoint Study Site

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Uveitis; Uveitis, Posterior; Uveitis, Intermediate

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Panuveitis

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

The Sponsor made the decision to stop study enrollment and terminate the study for reasons other than safety or efficacy in early May 2022 upon receipt of FDA comments on the clinical program in January 2022.

Results Point of Contact

• Title: Ramiro Ribeiro, MD, PhD
• Organization: EyePoint Pharmaceuticals, Inc.

rribeiro@eyepointpharma.com

908-440-0979

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: October 13, 2021
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Locations

US (1)