Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema (FAME)

Alimera Sciences

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: fluocinolone acetonide; Procedure: Standard of care laser photocoagulation; Drug: Fluocinolone Acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00344968

C-01-05-001

Details and patient eligibility

About

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

Enrollment: 956 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 19-68 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

956 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: fluocinolone acetonide

2

Experimental group

Treatment:

Drug: Fluocinolone Acetonide

3

Sham Comparator group

Treatment:

Procedure: Standard of care laser photocoagulation