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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00576459
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: 0.59 mg fluocinolone acetonide intravitreal implant Drug: 2.1 mg fluocinolone acetonide intravitreal implant Procedure: standard of care laser photocoagulation Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema
Study Start Date : March 2003
Primary Completion Date : June 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluocinolone acetonide 0.59 mg
0.59 mg fluocinolone acetonide intravitreal implant
Drug: 0.59 mg fluocinolone acetonide intravitreal implant
0.59 mg
Other Name: Retisert
Experimental: Fluocinolone acetonide 2.1 mg
2.1 mg fluocinolone acetonide intravitreal implant
Drug: 2.1 mg fluocinolone acetonide intravitreal implant
2.1 mg
Active Comparator: Laser photocoagulation
standard of care laser photocoagulation
Procedure: standard of care laser photocoagulation
standard of care laser photocoagulation

Primary Outcome Measures :
  1. Between group difference in mean visual acuity change (from baseline) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Differences in the proportions of subjects in each treatment group experiencing changes in: the area of retinal thickening; retinal leakage and cystoid scores; grade of diabetic retinopathy [ Time Frame: 1 year ]
  2. Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg [ Time Frame: throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with type 1 or 2 diabetes.
  • Subjects with clinically significant macular edema as defined by the ETDRS.
  • A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart.
  • Subjects with laser treatment status/history as follows: [1] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, [2] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula.
  • The subject's ocular media had to be sufficiently clear to allow for quality fundus photography.
  • If aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening.
  • Subjects had to be males or non-pregnant females of at least 18 years.
  • Subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an Informed Consent Form.

Exclusion Criteria:

  • Subjects who have had previous grid macular photocoagulation for diffuse macular edema.
  • Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy.
  • History of or current retinal detachment requiring surgical treatment or a scleral buckle.
  • Diabetic Retinopathy that required immediate PRP.
  • Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.).
  • Glaucoma, or history of glaucoma in either the study eye or the fellow eye.
  • Ocular hypertension, or history of ocular hypertension requiring IOP lowering treatment.
  • A media opacity that precludes visualization and/or diagnosis of the status of the eye.
  • Concurrent coumadin therapy or known bleeding diathesis.
  • Subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease.
  • Concurrent treatment with a new investigational drug.
  • Subjects with a best-corrected visual acuity worse than +1.0 logMAR (20/200 or 35 ETDRS letters) in the fellow eye.
  • Pregnant or lactating females.
  • Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy.
  • History of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device.
  • Subjects with photophobia that will preclude the ability to do fundus evaluations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576459

The Chinese University of Hong Kong
Hong Kong, China
LV Prasad Eye Institute
Banjara Hills, Hyderabad, India, 500 034
Sponsors and Collaborators
Bausch & Lomb Incorporated
Principal Investigator: Taraprasad Das, MD LV Prasad Eye Institute
Principal Investigator: Dennis Lam Shun-Chiu, MD Chinese University of Hong Kong

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00576459     History of Changes
Other Study ID Numbers: 420-003
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs