A randomised control trial of alternative treatments to Inhibit VEGf in Age-related choroidal Neovascularisation(IVAN) - IVA

Belfast Health and Social Care Trust0 个研究点目标入组 600 人开始时间: 2007年11月29日最近更新: 2019年6月30日

试验速览

暂无简介。

•Adults of either sex aged 50 years and older;
•Newly referred for the treatment of nAMD in the first or second eye;
•Corrected distance logMAR visual acuity (VAlogMAR) =25 letters read on a standard ETDRS chart at 1 metre;
•Any component of the neovascular lesion (CNV, blood, serous pigment epithelial detachment, elevated blocked flourescence) involving the centre of the fovea.
•If a fellow eye develops CNV from AMD, it will be treated with the optimum locally available treatment.
•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

•Age less than 50 years
•Corrected VAlogMAR <25 letters at 1 metre;
•Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion;
•Greatest linear diameter >6000µm (equivalent to about 12 disc diameters)
•Argon laser treatment to the proposed study eye within the last 6 months
•Presence of thick blood involving the centre of the fovea
•Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy.
•Patients with 8 or more dioptres of myopia.
•Previous treatment with PDT or a VEGF inhibitor in the eye being considered for inclusion.
•Pregnant and or lactating women
•Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception
•Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms
•A past medical history of cardiovascular disease or cardiovascular comorbidity, e.g. previous myocardial infarction or stroke, current angina, will not be an exclusion criterion. However, such factors will be documented carefully at the time of recruitment, and the potential benefits and harms of treatment discussed carefully with potential participants.

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