Principal Investigator: Paul Bernstein
Keywords: age related eye disease , macular degeneration , intravitreal injection Department: Ophthalmology-Services
IRB Number: 00132274
Specialty: Ophthalmology
Sub Specialties: Retinal Diseases
Recruitment Status: Not yet recruiting

Contact Information

Barbara Hart
barbara.hart@hsc.utah.edu
801-581-6459

Simple Summary

To evaluate the safety and efficacy of intravitreal administration of Zimura in patients with dry age-related macular degeneration as measured by rate of change in the area of geographic atrophy

Inclusion Criteria

Ophthalmic Inclusion Criteria

The following inclusion criteria apply to the study eye (SE):

  • Non-foveal GA secondary to dry AMD. 

  • Total GA area ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively), determined by FAF screening images.

  • If GA is multifocal, at least one focal lesion should measure ≥ 1.25 mm2 (0.5 DA).

  • GA in part within 1500 microns from the foveal center.

  • 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. 

  • Clear ocular media and adequate pupillary dilatation in both eyes to allow for all imaging procedures, including good quality stereoscopic fundus photography and fundus autofluorescence.

  • Intraocular pressure of ≤ 21 mmHg or less in the SE.

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 for the 24-month duration of the study.

An amendment will be submitted if a partner of a participant becomes pregnant.

 

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.  (If CNV develops in either eye during the course of the study, please review Section 10.3, Development of Wet AMD During the Trial.) 

  • GA secondary to any condition other than AMD in either eye (e.g., druginduced).

  • 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.

  • Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve.

  • Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreomacular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).

  • Presence or history of idiopathic or autoimmune-associated uveitis in either eye.

  • Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence.  Patients should not be entered if there is likelihood that they will require cataract surgery in the SE during the study.

  • Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. 

  • 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.

  • History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.

  • Any sign of diabetic retinopathy in either eye.

General Exclusion Criteria

Any of the following underlying diseases including:

  • History or evidence of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional Class III or IV - see Appendix 17.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrhythmias requiring ongoing treatment.

  • History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.

  • Clinically significant impaired renal (serum creatinine >2.5 mg/dl or status post renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled after consultation with IVERIC bio. 

  • Stroke (within 12 months of trial entry).

  • Any major surgical procedure within 1 month of trial entry.

  • Previous therapeutic radiation in the region of the SE.

  • Any treatment with an investigational agent in the past 60 days for any condition.

  • Women who are pregnant or nursing.

  • Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the Zimura formulation.

  • History of systemic treatment with any anti-complement agent in the past or the likelihood of treatment with any systemic anti-complement agent during the study.

Participant Reimbursement

Participants will be paid $75 per visit for out of pocket expenses incurred to attend clinic visits, up to a maximum of $1,950 for all protocol visits during the 24 months of the study.