Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Information source: Alimera Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Edema
Intervention: Fluocinolone Acetonide (Drug); Fluocinolone Acetonide (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Alimera Sciences
Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert
of fluocinolone acetonide for the treatment of diabetic macular edema
Clinical Details
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Levels of fluocinolone acetonide in plasma and aqueous humor
Secondary outcome: Retinal Thickness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age >= 18 years with diabetic macular edema
- Diagnosis of diabetes mellitus types 1 or 2
- Best corrected visual acuity of ≥ 19 letters
- Retinal thickness > 250 microns by OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
Exclusion Criteria:
- Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with
IOP lowering agents
- Retinal or choroidal neovascularization due to ocular conditions other than diabetic
retinopathy
- Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
- Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
- Any ocular surgery within the last 3 months
- Retinal laser treatment within the last 3 months
- History of uncontrolled IOP elevation with steroid use that did not respond to topical
therapy
- Any lens opacity which impairs visualization of the posterior pole
Locations and Contacts
John Hopkins University, Baltimore, Maryland, United States
Additional Information
Starting date: August 2007
Ending date: October 2010
Last updated: March 3, 2008
|
