Study To Determine Efficacy of Aflibercept For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Doc. MUDr. Petr Kolár, PhD, Ocní klinika FN Brno0 个研究点目标入组 45 人开始时间: 2014年9月15日最近更新: 2020年2月1日

试验速览

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•1) Ability to provide written informed consent and comply with study assessments for the full duration of the study.
•2) Men and women = 50 years old; women has to be postmenopausal
•3) Definite characteristic signs of retinal angiomatous proliferation secondary to wet AMD as determined by clinical signs (retinal oedema, subretinal fluid, sub RPE fluid, retinal or subretinal hemorrhage) and angiography (minimally classic leakage on fluorescein angiography)
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•A subject who meets any of the following criteria will be excluded from the study.
•1) Prior treatment with ranibizumab, bevacizumab, pegaptanib, verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
•2) Previous subfoveal focal laser photocoagulation involving the foveal centre in the study eye
•3) Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding baseline
•4) History of pars plana vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
•5) Previous participation in any studies of investigational drugs within 1 month preceding baseline
•6) Subjects with scar or fibrosis making up >50% of the total lesion or scar, fibrosis, or atrophy involving the centre of the fovea in the study eye.
•7) Subjects with clinical evidence of diabetic macular oedema, diabetic retinopathy or any retinal vascular disease other than AMD in either eye.
•8) Subjects with other causes of CNV in the study eye.
•9) Subjects with history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
•10) Subjects with intraocular pressure >25 mmHg despite treatment with antiglaucoma medication in the study eye.
•11) Active intraocular, extraocular and periocular infection in either eye.

发起方

Doc. MUDr. Petr Kolár, PhD, Ocní klinika FN Brno