FAI insert (0.05 mg fluocinolone acetonide) for Uveitis

EyePoint Study Site, Waltham, MA
Uveitis+2 More ConditionsFAI Insert - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Intermediate Uveitis
  • Posterior Uveitis

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

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

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2 Treatment Groups

FAI insert (0.05 mg fluocinolone acetonide)
1 of 2
Sham Comparator
1 of 2

Active Control

Non-Treatment Group

12 Total Participants · 2 Treatment Groups

Primary Treatment: FAI insert (0.05 mg fluocinolone acetonide) · Has Placebo Group · Phase 3

Sham Comparator
Drug
ShamComparator Group · 1 Intervention: Sham Injector · Intervention Types: Drug
FAI insert (0.05 mg fluocinolone acetonide)
Drug
ActiveComparator Group · 1 Intervention: FAI Insert · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

EyePoint Pharmaceuticals, Inc.Lead Sponsor
13 Previous Clinical Trials
1,846 Total Patients Enrolled
4 Trials studying Uveitis
433 Patients Enrolled for Uveitis

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There may be additional requirements you need to meet to participate in the study, as outlined in the study's guidelines.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.