A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneratio
- Conditions
- geographic atrophy secondary to dry age-related macular degenerationMedDRA version: 20.0Level: PTClassification code 10075567Term: Dry age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-000676-38-EE
- Lead Sponsor
- IVERIC bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy secondary to dry age-related macular degeneration (AMD);Secondary Objective: n/a;Primary end point(s): Primary Efficacy Endpoint:<br>Mean rate of change in GA over 12 months measured by FAF at three time points:<br>Baseline, Month 6, and Month 12 (square root transformation)<br><br>Safety Endpoints:<br>• AEs<br>• Vital signs (pulse, systolic and diastolic blood pressure)<br>• Ophthalmic variables (BCVA, LLBCVA, IOP, and ophthalmic examination)<br>• ECG (12-lead)<br>• Laboratory variables (blood: hematology, renal function, hepatic function, and electrolytes; urinalysis);Timepoint(s) of evaluation of this end point: Baseline, Month 6, and Month 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable