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-IT
- Lead Sponsor
- IVERIC bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 of non-childbearing potential is defined as follows:
• Woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
• Woman >= 60 years of age
• Woman >= 40 and =< 60 years of age who fulfills at least one of the following
o A cessation of menses for at least 12 months and a folliclestimulating hormone (FSH) test confirming non-childbearing potential (refer to laboratory reference ranges for confirmatory levels)
o A cessation of menses for at least 24 months without FSH levels confirmed
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.
If patient is a woman of childbearing potential, she must have a negative serum pregnancy test within 14 days prior to the first injection and have no plans to donate ova during the duration of the trial and at least 90 days following the last dose of test medication.
If patient is a male, the patient should use condom and not donate sperm during the time of study drug exposure and for 90 days following last exposure of study drug
- Provide written informed consent.
- Ability to return for all trial visits for the 24-month duration of the study.
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PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF INCLUSION CRITERIA
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.
...
PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF EXCLUSION CRITERIA
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: Not Applicable;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