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Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema
This study has been completed.
Sponsored by: Bausch & Lomb, Inc.
Information provided by: Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier: NCT00576459
  Purpose

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 Intervention 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 II

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Edema
Drug Information available for: Fluocinolone Fluocinolone acetonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:
  • Between group difference in mean visual acuity change (from baseline) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2003
Study Completion Date: July 2006
Arms Assigned Interventions
1: Experimental Drug: 0.59 mg fluocinolone acetonide intravitreal implant
0.59 mg
2: Experimental Drug: 2.1 mg fluocinolone acetonide intravitreal implant
2.1 mg
3: Active Comparator Procedure: standard of care laser photocoagulation
standard of care laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576459

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

Responsible Party: Bausch & Lomb ( Timothy L. Comstock )
Study ID Numbers: 420-003
Study First Received: December 18, 2007
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00576459  
Health Authority: United States: Food and Drug Administration;   Hong Kong: Department of Health;   India: Drugs Controller General of India

Study placed in the following topic categories:
Signs and Symptoms
Macular Edema
Fluocinolone Acetonide
Eye Diseases
Retinal Degeneration
Macular Degeneration
Edema
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009