Title
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
Phase
Phase 3Lead Sponsor
Alimera SciencesStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Diabetic Macular EdemaIntervention/Treatment
fluocinolone acetonide ...Study Participants
37This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
0.5 mg fluocinolone acetonide intravitreal insert
0.2 mg fluocinolone acetonide intravitreal insert
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
| Event Type | Organ System | Event Term | Fluocinolone Acetonide: 0.2 ug/Day Implant | Fluocinolone Acetonide: 0.5 ug/Day Implant |
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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.
