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Corticosteroid

FAI insert (0.05 mg fluocinolone acetonide) for Uveitis

Phase 3

Waitlist Available

Research Sponsored by EyePoint Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is testing a new type of eye insert to see if it is safe and effective in treating uveitis, a condition that causes inflammation in the eye.

Eligible Conditions

Uveitis
Posterior Uveitis
Intermediate Uveitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects who have a recurrence of uveitis in the study eye within 24 weeks (6 months) after receiving study treatment

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: FAI insert (0.05 mg fluocinolone acetonide)Active Control1 Intervention

FAI insert (0.05 mg fluocinolone acetonide)

Group II: Sham ComparatorPlacebo Group1 Intervention

sham injection

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

EyePoint Pharmaceuticals, Inc.Lead Sponsor

16 Previous Clinical Trials

1,919 Total Patients Enrolled

4 Trials studying Uveitis

433 Patients Enrolled for Uveitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research looking for new participants at the moment?

"The study, which can be found on clinicaltrials.gov, is currently looking for patients to enroll. The date that the trial was first posted was November 17th, 2021 and the most recent update was December 2nd, 2021."

Answered by AI

Is the data from this study unique to FAI insert (0.05 mg fluocinolone acetonide)?

"There are 5 ongoing studies investigating the efficacy of FAI insert (0.05 mg fluocinolone acetonide). Out of these 5, 2 are in Phase 3. Most of these studies are based in Durham, but there are 62 total research sites."

Answered by AI

Has the FDA cleared FAI insert (0.05 mg fluocinolone acetonide) for public use?

"There is both pre-existing clinical data and multiple rounds of safety data supporting the use of FAI insert (0.05 mg fluocinolone acetonide), which our team has rated a 3 on our safety scale."

Answered by AI

What is the primary purpose for which FAI insert (0.05 mg fluocinolone acetonide) is used?

"FAI insert (0.05 mg fluocinolone acetonide) can be used to mitigate friction and pressure injuries. Additionally, it is sometimes prescribed to patients suffering from otitis media, bacterial dermatitis, and chronic disease."

Answered by AI

How many research subjects are a part of this clinical investigation?

"That is correct. The clinicaltrials.gov website indicates that this trial is still looking for participants. Sixty patients need to be enrolled, and recruitment is happening at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070728.