Fluocinolone Acetonide Implant for Posterior Uveitis

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

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.

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.

Is the fluocinolone acetonide implant safe for treating posterior uveitis?

The fluocinolone acetonide implant has been studied for safety in treating noninfectious posterior uveitis, with research showing it is generally safe, though there may be injection-related events and long-term side effects. ^{1 2 3 4 5}

How is the fluocinolone acetonide implant different from other drugs for posterior uveitis?

The fluocinolone acetonide implant is unique because it is placed directly inside the eye, releasing medication slowly over time to control inflammation in posterior uveitis, which can help prevent relapses and reduce the need for frequent injections or oral medications. ^{1 2 3 4 6}

What data supports the effectiveness of the fluocinolone acetonide implant treatment for posterior uveitis?

Research shows that the fluocinolone acetonide implant is effective in treating noninfectious posterior uveitis, as several studies have demonstrated its ability to manage this eye condition over long periods, such as three years, with positive results. ^{1 2 3 4 7}

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. United States pubmed.ncbi.nlm.nih.gov

Treatment of intractable posterior uveitis in pediatric patients with the fluocinolone acetonide intravitreal implant (Retisert). [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. [2022]

6. New Zealand 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. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Preventing relapse in non-infectious uveitis affecting the posterior segment of the eye - evaluating the 0.2 μg/day fluocinolone acetonide intravitreal implant (ILUVIEN®). [2022]