Clinical characterization of the treatment of diabetic macular edema with aflibercept in an outpatient setting by evaluation of a regional network of ophthalmologic care givers

Abteilung für Augenheilkunde, AKH Linz0 个研究点目标入组 50 人开始时间: 2015年7月23日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•-Men or post-menopausal women
•-Presence of clinically significant diabetic macular edema with central involvement, as determined by fundoscopy, optical coherence tomography and /or fluorescence angiography
•-Diabetes mellitus Typ I or Typ II
•-No treatment of diabetic macular edema of any kind within 3 months prior to inclusion
•-No other reason for macular edema or visual impairment except ametropia
•-Willingness and able to comply with clinic visits and study-related procedures
•-Proved a signed informed consent form
•-If both eyes show signs of center involving swelling secondary to DME, the eye with worse visual acuity will be included in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 50

•- Inability to communicate in German or English
•- Dementia; inability to follow commands
•- Untreated Epilepsy
•- Neoplastic disease
•- Active intraocular inflammation (grade trace or above) in the study eye.
•- Active or suspected ocular or periocular infection in the study eye.
•- Allergy to fluorescein
•- Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
•- Intraocular pressure > 30mm HG at screening

发起方

Abteilung für Augenheilkunde, AKH Linz