Fluocinolone Acetonide Implant Compared to Sham Injection 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); Standard of care laser photocoagulation (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Alimera Sciences
Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone
acetonide for the treatment of diabetic macular edema.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Visual Acuity
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 19-68 letters
- Retinal thickness > 250 micron 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 6 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
Atlanta, Georgia, United States
Additional Information
Starting date: September 2007
Last updated: January 2, 2008
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