EUCTR2020-000676-38-LV
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- IVERIC bio, Inc.
- Enrollment
- 400
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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