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Corticosteroid

Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis (Iluvien Trial)

Phase 1
Waitlist Available
Led By Glenn J. Jaffe, MD
Research Sponsored by Glenn Jaffe
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at screening, day 0, day 1, day 14, day 28, months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this study is to determine the tolerability, safety, and benefits of an investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room. Initially, this was a 2-dose randomized pilot study. However, the study was modified to include only the 0.2 ug/day implant.

Eligible Conditions
  • Choroiditis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at screening, day 0, day 1, day 14, day 28, months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at screening, day 0, day 1, day 14, day 28, months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in status of uveitis in study eye.
Secondary study objectives
Eye
Change in IOP (intraocular pressure) in study eye.
Change in endophthalmitis in study eye.
+4 more

Side effects data

From 2010 Phase 3 trial • 956 Patients • NCT00344968
31%
Cataract
22%
Cataract operation
15%
Hypertension
13%
Intraocular pressure increased
13%
Conjunctival haemorrhage
12%
Vitreous haemorrhage
11%
Anaemia
8%
Nausea
8%
Visual impairment
7%
Constipation
7%
Gastrooesophageal reflux disease
7%
Vitrectomy
6%
Trabeculectomy
6%
Eye irritation
6%
Maculopathy
6%
Nasopharyngitis
6%
Urinary tract infection
6%
Hypercholesterolaemia
6%
Depression
6%
Visual acuity reduced
6%
Sinusitis
6%
Renal failure
6%
Cataract subcapsular
5%
Posterior capsule opacification
5%
Myodesopsia
5%
Vitreous detachment
5%
Upper respiratory tract infection
5%
Headache
5%
Cough
4%
Cardiac failure congestive
4%
Coronary artery disease
4%
Vision blurred
4%
Myocardial infarction
4%
Dry eye
4%
Retinal haemorrhage
3%
Pneumonia
3%
Eye pain
3%
Cerebrovascular accident
3%
Trabeculoplasty
2%
Cellulitis
2%
Angina pectoris
2%
Vomiting
2%
Gangrene
1%
Toe amputation
1%
Cardiomyopathy
1%
Chest pain
1%
Gastroenteritis
1%
Diabetes mellitus
1%
Hip fracture
1%
Cardiac arrest
1%
Renal failure chronic
1%
Glaucoma surgery
1%
Glaucoma
1%
Infection
1%
Cardiac disorder
1%
Syncope
1%
Renal failure acute
1%
Oedema
1%
Dehydration
1%
Nephrolithiasis
1%
Transurethral prostatectomy
1%
Bradycardia
1%
Vertigo
1%
Angle closure glaucoma
1%
Diabetic gastroparesis
1%
Localised infection
1%
Fall
1%
Hip arthroplasty
1%
Open angle glaucoma
1%
Pancreatitis
1%
Arthritis bacterial
1%
Sepsis
1%
Wound infection staphylococcal
1%
Femur fracture
1%
Pelvic fracture
1%
Catheterisation cardiac
1%
Diabetes mellitus inadequate control
1%
Hyperglycaemia
1%
Hypoglycaemia
1%
Muscular weakness
1%
Hemiparesis
1%
Transient ischaemic attack
1%
Dyspnoea
1%
Respiratory failure
1%
Coronary artery bypass
1%
Angina unstable
1%
Ocular hypertension
1%
Hysterectomy
1%
Intraocular lens implant
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluocinolone Acetonide: 0.5 ug/Day Implant
Sham Comparator
Fluocinolone Acetonide: 0.2 ug/Day Implant

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Low dose FA-i (Fluocinolone Acetonide insert)Experimental Treatment1 Intervention
Each FA-i contains 180 µg FA (Fluocinolone Acetonide) designed to be released over 15 - 30 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluocinolone acetonide
FDA approved

Find a Location

Who is running the clinical trial?

Glenn JaffeLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
Glenn J. Jaffe, MDPrincipal InvestigatorDuke University Eye Center
~1 spots leftby Dec 2025
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