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 Age-Related Macular Degeneration - GATHER2

IVERIC bio, Inc.0 个研究点目标入组 400 人开始时间: 2020年11月1日最近更新: 2021年4月12日

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•Ophthalmic Inclusion Criteria
•The following inclusion criteria apply to the study eye (SE), one study eye per patient. If both eyes satisfy the inclusion criteria, it is in the investigator’s discretion to determine 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
•\- Patients of either gender aged \= 50 years.
•\- For patients who are women of childbearing potential involved in any sexual intercourse that could lead to pregnancy, the patient has used a protocol approved highly effective contraceptive method during the trial and agrees to continue the same method until at least 90 days following the last dose of test medication. Protocol approved highly effective contraceptive methods are hormonal contraceptives (i.e., combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, abstinence as defined by refraining from
•heterosexual intercourse during the entire period of the study and until at least 90 days following the last dose of study medication, vasectomy, and
•tubal ligation. A woman of non\-childbearing potential is defined as follows:

•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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