Fluocinolone Acetonide Implant for Posterior Uveitis

Not currently recruiting at 27 trial locations

Overseen By Niti Rao

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Alimera Sciences

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Diabetes, Glaucoma, Ocular infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tiny implant called YUTIQ® (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) to determine its safety and effectiveness in managing chronic eye inflammation, known as posterior uveitis, that has previously improved with steroid treatments. The goal is to assist individuals who have dealt with this eye condition for at least three months. Suitable candidates have experienced relief from past steroid treatments, have ongoing inflammation in the back part of their eye, and do not plan any eye surgeries soon. As a Phase 4 trial, YUTIQ® is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on more than two medications to lower eye pressure or on certain steroids, you might need to adjust your treatment. It's best to discuss your specific medications with the study team.

What is the safety track record for the Fluocinolone Acetonide Intravitreal Implant?

Research has shown that the fluocinolone acetonide implant, used to treat non-infectious posterior uveitis, is generally safe and well-tolerated. In some studies, a few patients experienced increased eye pressure, occasionally requiring surgery, though these cases were uncommon. The implant releases medication slowly over time, effectively controlling inflammation. As this treatment is in the later stages of clinical trials, extensive safety information suggests that serious side effects are likely rare. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Fluocinolone Acetonide Intravitreal Implant for posterior uveitis because it offers a new way to manage this challenging eye condition. Unlike traditional treatments that often include systemic corticosteroids or immunosuppressive drugs, this implant delivers a low dose of fluocinolone acetonide directly into the eye. This targeted delivery method minimizes systemic side effects while providing sustained anti-inflammatory effects right where they're needed. The implant's ability to provide long-term treatment with a single application is a game-changer, potentially reducing the need for frequent injections or systemic medication adjustments.

What is the effectiveness track record for the Fluocinolone Acetonide Intravitreal Implant in treating posterior uveitis?

Research has shown that the fluocinolone acetonide implant effectively treats non-infectious posterior uveitis, a type of eye inflammation. Studies have found that this implant significantly reduces uveitis flare-ups, improves vision, and decreases the need for additional treatments. Previous research suggests that the benefits for eye health can last a long time with this treatment. The implant releases a small, steady amount of medicine directly into the eye to control inflammation. It has a manageable safety profile, indicating that the risks are generally low and acceptable. This treatment is already approved and effective for this condition. ^{2 5 6 7 8}

Who Is on the Research Team?

Antonio Cutino

Principal Investigator

Alimera Sciences Inc

Are You a Good Fit for This Trial?

Adults at least 18 years old with chronic non-infectious uveitis affecting the back of the eye, who've seen improvement with steroid treatments. They should have macular edema and a certain level of vision clarity. Excluded are those with high eye pressure on multiple medications, recent eye surgeries or infections, known allergies to YUTIQ ingredients, certain systemic conditions requiring steroids or immunosuppressants, pregnant women, and other specific ocular conditions.

Inclusion Criteria

I am at least 18 years old and in good health.

I am willing and able to follow the study's schedule and procedures.

Presence of macular edema as measured by spectral-domain - optical coherence tomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on Zeiss CIRRUS)

Exclusion Criteria

My glaucoma or high eye pressure is under control with up to 2 medications or surgery.

I have not had eye surgery in the last 12 weeks.

I have not had radiation to my head or neck in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at Months 1, 3, 6, 12, 18, and 24

What Are the Treatments Tested in This Trial?

Interventions

• Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Trial Overview The trial is testing YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) for its effectiveness in controlling inflammation in the back part of the eye due to uveitis that has previously responded to steroids. The implant's safety profile will also be assessed.

How Is the Trial Designed?

Group I: Fluocinolone Acetonide 0.18 mg Experimental Treatment 1 Intervention

Fluocinolone Acetonide Intravitreal Implant 0.18 mg

Who Is Running the Clinical Trial?

Alimera Sciences

Lead Sponsor

Trials

14

Recruited

3,000+

EyePoint Pharmaceuticals, Inc.

Lead Sponsor

Trials

19

Recruited

2,700+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Published Research Related to This Trial

Long-acting fluocinolone intravitreal implants have been approved for treating non-infectious uveitis in the posterior segment, demonstrating effective drug delivery and sustained release.

The systematic review of pivotal phase 3 studies indicates that these implants are generally safe, with manageable injection-related events and long-term adverse effects, making them a viable treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment. Steeples, LR., Pockar, S., Jones, NP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150361/

The effectiveness of the 0.19 mg fluocinolone acetonide ... Our results suggest improvements and long-term maintenance in functional and anatomical outcomes with FAc implant with a manageable safety profile.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16690128/

Fluocinolone acetonide implant (Retisert) for noninfectious ... The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population.

3. bauschretinarx.com bauschretinarx.com/retisert/ecp/efficacy/

long-term control is possible with retisert - Bausch and Lomb Use of the fluocinolone acetonide intravitreal implant for the treatment of noninfectious posterior uveitis: 3-year results of a randomized clinical trial in a ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00407082

Safety and Efficacy of Fluocinolone Acetonide Intravitreal ... This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) intravitreal implants for ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/09273948.2023.2296031

Long-Term Clinical Outcomes of the 0.18 Mg Fluocinolone ... This treatment approach demonstrates that the 0.18 mg FAi is a useful adjuvant for the treatment of noninfectious uveitis but may not be adequate as solo ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39630970/

Efficacy and Safety of Fluocinolone Acetonide 0.19 mg ... This systematic review evaluates the real-world efficacy and safety of the 0.19 mg fluocinolone acetonide (FAc) sustained-release intravitreal implant for ...

7. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2798349

CALM: 24-month safety outcomes from a real-world registry ... Safety data included intraocular pressure (IOP) elevation and rates of surgical interventions. Results : A total of 243 eyes from 182 patients received the FAc ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15921758/

Long-term follow-up results of a pilot trial of a fluocinolone ... Abstract. Purpose: To investigate the safety and efficacy of a fluocinolone acetonide intravitreal implant in the treatment of noninfectious posterior uveitis.