Subretinal Macugen for neovascular age-related macular degeneration (SUMANA) - SUMANA

Society (Institute) for clinical research0 个研究点开始时间: 2009年1月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Subjects meeting all of the following criteria will be considered for admission to the trial:
•adults aged 50 years and older with neovascular AMD proven by fluorescein angiography
•Patients who at baseline
•- have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent
•-have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
•- Evidence that CNV extends under the geometric center of the foveal avascular zone.
•Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given:
•- Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either
•- =10% increase in the lesion diameter as assessed by fluorescein angiography in the
•previous 3 months
•Ability of subject to understand character and individual consequences of clinical trial.
•Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
•Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Subjects presenting with any of the following criteria will not be included in the trial:
•have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion)
•had previous vitrectomy surgery for whatsoever reason
•are not pseudophakic
•have a >50% area of scarring of the whole CNV lesion size as seen in FA
•Arterial hypertension refractory to medical treatment
•Pregnancy and lactation.
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
•Participation in other clinical trials during the present clinical trial or within the last 3 months.
•Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
•Suspected or present ocular or periocular infection

发起方

Society (Institute) for clinical research