Diabetic Macular Oedema
Conditions
Interventions
Product Name: ASI- 001B 0.2 Ug/day
Pharmaceutical Form: Ophthalmic insert
INN or Proposed INN: Fluocinolone Acetonide
Concentration unit: µg microgram(s
Sponsors
Alimera Science Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and non-pregnant females at least 18 years of age - Best corrected visual acuity (BCVA) of >19 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, IUD) - Laser treatment for diabetic macular edema 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 (i.e. triamcinolone injection) 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 > 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 (i.e. presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration) - Any active viral, fungal or baterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (eg. Occular herpes simplex virus) - Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids - History of vitrectomy in 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 area of insertion - Participation in another clinical treatment trial within 12 weeks of screening or during the study - Resting systolic blood pressure of greater than 180 or diastolic blood pressure greater than 105 at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate high dose and low dose Sustained release Fluocinolone Acetonide Insert in the management of patients with Diabetic Macular Oedema. ; Secondary Objective: 1. To chose the optimum dose level for intravitreal fluocinolone acetonide 2. To compare the two dose levels versus the control group at other timepoints 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 =15 letters in VA score; assessed at Month 24 as the primary endpoint. There will be three secondary efficacy variables defined at month 24: 1. Mean change from the baseline in best corrected VA letter score as assessed by EDTRS eye chart 2. Mean change from baseline in excess average foveal thickness as assessed by OCT 3. Proportion of subjects with a>=3 step worsening in the study eye compared to baseline in the ETDRS Multi-Step Eye Scale of Diabetic Retinopathy | — |
Countries
Italy, Portugal, Spain, United Kingdom
Outcome results
None listed