Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502541

Enrollment

196

Registered

2007-07-17

Start date

2001-09-30

Completion date

2006-09-30

Last updated

2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief summary

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Interventions

DRUGfluocinolone acetonide

fluocinolone acetonide 0.59 mg intravitreal implant

PROCEDUREStandard of Care

Repeat macular grid laser or observation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and nonpregnant females at least 18 years of age, with DME in the study eye * Edema must involve fixation and be at least 1 disc area in size * Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye * The study eye must have received at least one macular laser treatment \> 12 weeks prior to entry into the study * Ability and willingness to comply with treatment and follow-up * Ability to understand and sign the Informed Consent form

Exclusion criteria

* Pregnant, lactating females * Allergy to fluocinolone acetonide or any component of the delivery system * Any disease or condition that would preclude study treatment or follow up * Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s). * History of uncontrolled IOP within the last 12 months

Design outcomes

Primary

Measure	Time frame
A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage	at 26 weeks and yearly through completion of the study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026