A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneratio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 400

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 < 60 years of age who fulfills at least one of the
following:
- 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)
- A cessation of menses for at least 24 months without FSH levels
confirmed
If the 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. Ireland, Slovakia, United Kingdom,
Czech Republic, Poland, France, Italy: If the patient is male, he should
use a condom and not donate sperm during the time of study drug
exposure and for 90 days following the last exposure of study drug
- 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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method