geographic atrophy secondary to dry age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10075567 Term: Dry age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
IVERIC bio, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: • A woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) • A woman = 60 years of age A woman = 40 and =65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 age-related macular degeneration (AMD);Secondary Objective: n/a;Primary end point(s): Primary Efficacy Endpoint: The mean rate of growth (slope) estimated based on GA area measured by FAF in at least 3 time points: Baseline, Month 6, and Month 12 (square root transformation) Safety Endpoints: • AEs • Vital signs (pulse, systolic and diastolic blood pressure) • Ophthalmic variables (BCVA, LLBCVA, IOP, and ophthalmic examination) • ECG (12-lead) • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactDirector Global Regulatory Affairs
IVERIC bio, Inc.
Outcome results
None listed