A Phase 2b Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

OPHTHOTECH CORPORATIO0 个研究点目标入组 200 人开始时间: 2018年1月31日最近更新: 2019年2月28日

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•Ophthalmic Inclusion Criteria
•The following inclusion criteria apply to the SE:
•- Non-foveal GA secondary to dry AMD.
•- The atrophic lesion must be able to be photographed in its entirety.
•- Best corrected visual acuity in the SE between 20/25 – 20/320, inclusive.
•General Inclusion Criteria
•- Subjects of either gender aged =50 years.
•- Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
•- Provide written informed consent.
•- Ability to return for all trial visits.
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Exclusion Criteria
•Subjects will not be eligible for the trial if subjects cannot attend all trial required visits, or if any of the following criteria are present systemically or in the SE:
•Ophthalmic Exclusion Criteria
•The following exclusion criteria apply to the SE:
•- Evidence of CNV in either eye.
•- Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals.
•- Presence of other causes of choroidal neovascularization.
•- Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
•- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
•- Any sign of diabetic retinopathy in either eye.

发起方

OPHTHOTECH CORPORATIO