E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate high dose and low dose Sustained release Fluocinolone Acetonide Insert in the management of patients with Diabetic Macular Oedema. |
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E.2.2 | Secondary objectives of the trial |
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 efficacy of ASI-001A and ASI-001B in DME and diabetic retinopathy using the relevant measures
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and non-pregnant females at least 18 years of age, Best corrected visual acuity (BCVA) of >19 and <68 letters by ETDRS in the study eye. BCVA of the non-study eye must be no worse than 20/400, Diagnosis of diabetes mellitus (type 1 or type 2), At least one macular laser treatment > 12 weeks prior to screening visit, Diabetic macular edema based on investigator’s clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and OCT despite previous laser , Mean foveal thickness of at least 250 µm by OCT, Ability and willingness to comply with treatment and follow up process, Ability to understand and sign the Informed Consent Form
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E.4 | Principal 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 6 months prior to enrollment (i.e. triamcinolone injection), 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 viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, any fungal disease of any ocular structure, or history of infectious retinitis, 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, Peripheral retinal detachment in area of insertion, Participation in another clinical treatment trial within 12 weeks of screening or during the study
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Proportion of subjects who have an increase from baseline of ≥15 letters in VA score; assessed at Months 18 and 36 as co-primary endpoints 2. Proportion of subjects who have a ≥2 step worsening compared to baseline in the ETDRS Multi-Step Scale of Diabetic Retinopathy; assessed at Month 36 as a co-primary endpoint
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Laser Coagulation (Standard of Care) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |