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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

956 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00490815

Diabetic Macular Edema

COMPLETED PHASE3

Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema

NCT00576459

Diabetic Macular Edema

COMPLETED PHASE2

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

NCT00502541

Diabetic Macular Edema

COMPLETED PHASE2/PHASE3

Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

NCT04910503

Diabetic Macular Edema

RECRUITING PHASE4

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

NCT01304706

Diabetic Macular Edema

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

fluocinolone acetonide

Intervention Type DRUG

0.5 mg fluocinolone acetonide intravitreal insert

2

Group Type EXPERIMENTAL

Fluocinolone Acetonide

Intervention Type DRUG

0.2 mg fluocinolone acetonide intravitreal insert

3

Group Type SHAM_COMPARATOR

Standard of care laser photocoagulation

Intervention Type PROCEDURE

Laser photocoagulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fluocinolone acetonide

0.5 mg fluocinolone acetonide intravitreal insert

Intervention Type DRUG

Fluocinolone Acetonide

0.2 mg fluocinolone acetonide intravitreal insert

Intervention Type DRUG

Standard of care laser photocoagulation

Laser photocoagulation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No