EUCTR2014-003491-23-PTActive, not recruitingPhase 1
A non-randomised, open-label, multicenter phase 4 pilot study on the effect and safety of Iluvien® in chronic diabetic macular edema patients considered insufficiently responsive to available therapies with or without intravitreal corticosteroid therapy. (RESPOND) - RESPOND
AIBILI – Association for Innovation and Biomedical Research on Light and Image0 sitesStarted: October 14, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients =18 years of age, of either sex that have signed informed consent.
- •2. Chronic DME, defined as a history of macular edema with duration > 1 year having already received other therapy, based on investigator’s clinical evaluation and demonstrated using fundoscopic photography and SD-OCT.
- •3. Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:
- •Mean central foveal thickness (central subfield thickness) = 290um in women and = 305um in men in Zeiss Cirrus OR = 305um in women and = 320um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT;
- •Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
- •If in the Investigator’s opinion a further improvement is possible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
Exclusion Criteria
- •1. IOP > 21 mmHg at screening (day -14) in the study eye.
- •2. Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- •3. Use of = 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
- •4. Patients that have vitreomacular traction in DME and opaque media in the study eye.
- •5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
- •6. Pregnant or breastfeeding women.
- •7. Patients diagnosed with active angiographic central macular ischaemia prior to screening in the study eye.
- •8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the screening visit in the study eye.
- •9. Patients with contraindications:
- •a. Presence of pre-existing glaucoma.
- •b. Active or suspected ocular or periocular infection.
- •c. The patient is hypersensitive to the active agent or to one of the excipients.
- •10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices – IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
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