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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00576459
First received: December 18, 2007
Last updated: December 7, 2011
Last verified: July 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

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
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00576459     History of Changes
Other Study ID Numbers: 420-003
Study First Received: December 18, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
India: Drugs Controller General of India

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

ClinicalTrials.gov processed this record on July 22, 2014