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Corticosteroid
Fluocinolone Acetonide Implant for Posterior Uveitis
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, 12, 18, and 24
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BCVA
Change in CST
Secondary outcome measures
Change from baseline in CST
Change in BCVA letter score
Presence of vascular leakage
+2 moreTrial 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
12 Previous Clinical Trials
2,809 Total Patients Enrolled
EyePoint Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
1,806 Total Patients Enrolled
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
1,158 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the US Food and Drug Administration given its approval to Fluocinolone Acetonide Intravitreal Implant 0.18 mg?
"There is a substantial amount of past evidence that suggests Fluocinolone Acetonide Intravitreal Implant 0.18 mg is safe for use, so the drug was assigned a score of 3 in our evaluation process."
Answered by AI
How many trial sites have been allocated for this research endeavor?
"This clinical trial includes 17 centres, including the Athena Eye Institute in Katy, California; The California Eye Specialist Medical Group in San Antonio, Missouri; and Macula & Retina Institute in Redlands, Georgia."
Answered by AI
What aims does the research seek to achieve?
"The 6-month trial's primary outcome is the alteration of BCVA. Additionally, it will monitor for vascular leakage through wide field fluorescein angiography and macular edema resolution with SD OCT scans. It will also track any changes in BCVA letter scores from baseline levels as measured by EDTRS measurements."
Answered by AI
Is this research endeavor still seeking participants?
"As evidenced on clinicaltrials.gov, this medical investigation is still accepting volunteers. The trial was created on June 6th 2022 and has undergone its most recent review on August 18th 2022."
Answered by AI
To what extent are individuals participating in this research endeavor?
"The clinical trial's sponsor, EyePoint Pharmaceuticals Inc., mandates 125 participants that meet the eligibility criteria. Athena Eye Institute in Katy, California and California Eye Specialist Medical Group in San Antonio, Missouri are two of many potential locations for this endeavor."
Answered by AI
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