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Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Phase 3
Completed
Conditions
Diabetic Macular Edema
Interventions
Registration Number
NCT00490815
Lead Sponsor
Alimera Sciences
Brief Summary

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2Fluocinolone Acetonide-
1Fluocinolone Acetonide-
Primary Outcome Measures
NameTimeMethod
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humorover 36 months

This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.

Secondary Outcome Measures
NameTimeMethod
Retinal Thicknessover 36 months

Trial Locations

Locations (1)

John Hopkins University

🇺🇸

Baltimore, Maryland, United States

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