A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 µg/day and ASI-001B 0.2 µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema - FAME

• Conditions: Diabetic Macular Edema; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2006-001035-22-IT
• Lead Sponsor: ALIMERA SCIENCES INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-24
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

?Males and non-pregnant females at least 18 years of age
?BCVA of ≥19 and ≤68 letters in the study eye by an ETDRS chart.
?BCVA of the non-study eye must be no worse than 20/400
?Diagnosis of diabetes mellitus (type 1 or type 2):
oUse of insulin for the treatment of diabetes for at least the 3 months prior to screening
oUse of oral ant hyperglycemia agents for the treatment of diabetes for at least the 3 months prior to screening
?DME based on investigator's clinical evaluation and demonstrated on funds photographs, fluorescein angiograms, and optical coherence tomography (OCT)
?Mean foveal thickness of at least 250 µm by OCT
?Ability and willingness to comply with the treatment and follow up procedures
?Ability to understand and sign the Informed Consent Form.
?At least one macular laser treatment more than 12 weeks prior to the screening visit
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
?Laser treatment for DME within 12 weeks of screening or judged to be necessary within 6 weeks following enrollment
?Any ocular surgery in the study eye within 12 weeks of screening
?Yag capsulotomy in the study eye within 15 days of screening
?Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to enrollment (e.g., triamcinolone) or prior treatment with intravitreal anti-VEGF treatment within 2 months of enrollment (Lucentis, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed within 3 months prior to screening.
?Any change in systemic steroidal therapy within 3 months of screening
?Glaucoma, ocular hypertension, intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with IOP-lowering agents in the study eye
?Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)
?Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus).
? Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
?History of vitrectomy in the study eye
?History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
?History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
?Any lens opacity which impairs visualization of the posterior pole or significantly impairs vision, in the opinion of the investigator.
?Peripheral retinal detachment in prospective area of insertion
?Participation in another clinical trial within 12 weeks before the screening visit or during the study
?Resting Systolic blood pressure at the screening visit of greater than 180 or diastolic blood pressure greater than 105.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate high dose and low dose Sustained release Fluocinolone Acetonide Insert in the management of patients with Diabetic Macular Edema;Secondary Objective: 1. To chose the optimum dose level for intravitreal fluocinolone acetonide<br>2. To compare the two dose levels versus the control group at other timepoints<br>3. To evaluate the safety and efficacy of ASI-001A and ASI-001B in DME and diabetic retinopathy using the relevant measures;Primary end point(s): ?Proportion of subjects who have an increase from baseline of &#8805;15 letters in VA score assessed at Month 24 as the primary endpoint.<br>There will be two secondary efficacy variables defined at Month 24:<br>?Mean change from baseline in best corrected VA letter score as assessed by ETDRS eye chart.<br>?Proportion of subjects with a &#8805;2 step worsening in the study eye compared to baseline in the ETDRS Multi-Step Eye Scale of Diabetic Retinopathy.