Your session is about to expire
← Back to Search
Corticosteroid
Fluocinolone Acetonide Implant for Posterior Uveitis
Phase 4
Waitlist Available
Research Sponsored by Alimera Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not planning to undergo elective ocular surgery during the study
Be older than 18 years old
Must not have
Radiation to the head or neck within 2 years prior to Screening
Ocular surgery within 12 weeks prior to Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, 12, 18, and 24
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test a new, long-term treatment for uveitis, an inflammation of the eye. The goal is to see if the implant is safe and effective for patients who have responded to steroid therapy in the past.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include increased eye pressure which can lead to glaucoma, cataract formation or worsening if already present; possible risk of infection from the injection procedure; and less commonly retinal detachment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not planning any eye surgery during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had radiation to my head or neck in the last 2 years.
Select...
I have not had eye surgery in the last 12 weeks.
Select...
I do not have eye infections like herpes, shingles, or fungal diseases.
Select...
My eye pressure has been below 6 mmHg for over a month.
Select...
I do not have a detached retina or retinoschisis in my study eye.
Select...
I have not had eye injections with Retisert, ILUVIEN, or YUTIQ in the last 3 years.
Select...
I haven't had an OZURDEX® eye injection in the last 12 weeks.
Select...
My eye pressure is over 21 mmHg or I am on more than 2 medications to lower it.
Select...
I have a scar in my eye from toxoplasmosis or a past viral infection.
Select...
I have not had a YAG laser capsulotomy in the last 30 days.
Select...
I have eye inflammation caused by an infection.
Select...
I do not have any severe health or mental conditions that could make this study risky for me.
Select...
I have eye cancer, such as choroidal melanoma.
Select...
I have had viral retinitis in the past.
Select...
I have had macular edema due to diabetes, RVO, AMD, or a similar non-inflammatory cause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 1, 3, 6, 12, 18, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, 12, 18, and 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in BCVA
Change in CST
Secondary study objectives
Change from baseline in CST
Change in BCVA letter score
Presence of vascular leakage
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fluocinolone Acetonide 0.18 mgExperimental Treatment1 Intervention
Fluocinolone Acetonide Intravitreal Implant 0.18 mg
Find a Location
Who is running the clinical trial?
Alimera SciencesLead Sponsor
13 Previous Clinical Trials
2,834 Total Patients Enrolled
EyePoint Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
2,578 Total Patients Enrolled
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
1,158 Total Patients Enrolled
Dario A PaggiarinoStudy ChairEyePoint Pharmaceuticals, Inc.
Antonio CutinoStudy ChairAlimera Sciences Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am at least 18 years old and in good health.I am on a low dose of prednisone (less than 7.5 mg daily) for a condition that is not related to my eyes.I am not pregnant or nursing and willing to use birth control as required.I am willing and able to follow the study's schedule and procedures.You have an allergic reaction to any of the ingredients in YUTIQ®.I do not have eye infections like herpes, shingles, or fungal diseases.My eye pressure has been below 6 mmHg for over a month.I do not have a detached retina or retinoschisis in my study eye.I have not had eye injections with Retisert, ILUVIEN, or YUTIQ in the last 3 years.I have not had eye injections with Triesence or TRIVARIS in the last 12 weeks.I haven't had an OZURDEX® eye injection in the last 12 weeks.I have had non-infectious eye inflammation for at least 3 months.I am not planning any eye surgery during the study.I haven't had eye steroid treatments in the last 12 weeks.My eye inflammation improved with steroid treatments.My eye pressure is over 21 mmHg or I am on more than 2 medications to lower it.I have a scar in my eye from toxoplasmosis or a past viral infection.I have not had a YAG laser capsulotomy in the last 30 days.I have eye inflammation caused by an infection.I do not have any severe health or mental conditions that could make this study risky for me.I have eye cancer, such as choroidal melanoma.I have had viral retinitis in the past.I have had macular edema due to diabetes, RVO, AMD, or a similar non-inflammatory cause.You are allergic to steroids, especially fluocinolone.
Research Study Groups:
This trial has the following groups:- Group 1: Fluocinolone Acetonide 0.18 mg
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.