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

Bausch & Lomb Incorporated2 sites in 2 countries40 target enrollmentMarch 2003

Interventions0.59 mg fluocinolone acetonide intravitreal implant 2.1 mg fluocinolone acetonide intravitreal implant standard of care laser photocoagulation

Drugs0.59 mg fluocinolone acetonide intravitreal implant 2.1 mg fluocinolone acetonide intravitreal implant

Overview

Phase: Phase 2
Intervention: 0.59 mg fluocinolone acetonide intravitreal implant
Conditions: Diabetic Macular Edema
Sponsor: Bausch & Lomb Incorporated
Enrollment: 40
Locations: 2
Primary Endpoint: Between group difference in mean visual acuity change (from baseline)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

July 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Fluocinolone acetonide 0.59 mg

0.59 mg fluocinolone acetonide intravitreal implant

Intervention: 0.59 mg fluocinolone acetonide intravitreal implant

Fluocinolone acetonide 2.1 mg

2.1 mg fluocinolone acetonide intravitreal implant

Intervention: 2.1 mg fluocinolone acetonide intravitreal implant

Laser photocoagulation

standard of care laser photocoagulation

Intervention: standard of care laser photocoagulation

Outcomes

Primary Outcomes

Between group difference in mean visual acuity change (from baseline)

Time Frame: 1 year

Secondary Outcomes

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(1 year)
Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg(throughout study)