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

Alimera Sciences

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Fluocinolone Acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490815

C-01-06-002

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Fluocinolone Acetonide

Drug: Fluocinolone Acetonide

2

Experimental group

Treatment:

Drug: Fluocinolone Acetonide

Drug: Fluocinolone Acetonide