Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

Prior treatment

• At least 2 months following cataract removal in the study eye and Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks and any other ocular surgery in the study eye in the past 3 months prior to implantation;
• Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye.
• Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery;

Other illness

• History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, uncontrolled glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome;
• History of retinal detachment repair in the study eye;
• History of cognitive impairments or dementia;
• History of any condition other than AMD associated with choroidal neovascularization in the study eye (e.g. pathologic myopia or presumed ocular histoplasmosis);
• Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the patient at special risk.
• History of cancer (other than a non-melanoma skin cancer). For cancers in remission more than five years ago, enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment.

Other

• Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye;
• Axial myopia greater than -6 diopters;
• Contraindication for systemic immunosuppression;
• Pregnancy or breastfeeding;

• Age 50 and older;
• Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes;
• Funduscopic findings of dry age-related macular degeneration (AMD) with progressive geographic atrophy in the macula;
• Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing;
• Vision in the non-operated eye must be better than or equal to that in the operated eye;
• Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow up period (based on medical records);
• Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care;
• Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance;
• Negative for tuberculosis (TB) (cohort 4), human immunodeficiency virus (HIV), hepatitis B (HBC), and hepatitis C virus (HCV), negative for cytomegalovirus (CMV) Immunoglobulin (IgM) and Epstein-Barr Virus (EBV) IgM or asymptomatic in the opinion of the investigator (cohort 4);
• No history of malignancy (other than a non-melanoma skin cancer). For cancers in remission for more then 5 years enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment;
• Willing to defer all future blood and tissue donation;
• Able to understand study procedures and willing to sign informed consent.