A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of IntravitrealAdministration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

IVERIC bio, Inc.0 个研究点目标入组 400 人开始时间: 2020年5月10日最近更新: 2024年3月18日

适应症

试验速览

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•Ophthalmic Inclusion Criteria
•The following inclusion criteria apply to the study eye (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
•- Patients of either gender aged = 50 years.
•- Women must be using two forms of effective contraception, be postmenopausal 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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 320

•Patients will not be eligible for the trial if patients 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 (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals.
•- Any ocular condition in the SE that would progress during the course of the study that could affect central vision or otherwise be a confounding factor.
•- 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.

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