A prospective, non-randomised, multicenter study on the efficacy and safety of ILUVIEN® in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT) - REACT

Dr. José Maria Ruiz Moreno0 个研究点开始时间: 2016年8月11日最近更新: 2016年10月31日

试验速览

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•1.Patients =18 years of age, of either sex that have signed informed consent.
•2.DME 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/or corticoesteroids injections 6 months ago or more, and meet the following:
•-Mean central foveal thickness (central subfield thickness) = 290 µm in women and = 305 µm in men in Zeiss Cirrus OR = 305µm in women and = 320 µm in men in Heidelberg Spectralis, or equivalent accordingly with Tocon or Swep Source, 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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.IOP > 21 mmHg at screening 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 child-bearing potential women who do not want to use contraception methods during the study period.
•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.
•The patient is hypersensitive to the active agent or to one of the excipients.

发起方

Dr. José Maria Ruiz Moreno