A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration

Study inclusion criteria:

• To participate in this study, the participant had to understand and sign the protocol's informed consent (if the participant's vision was impaired to the point where it was not possible to read the informed consent document, the informed consent document was read in its entirety to the participant).
• Women of childbearing potential (women with last menses or = 4 weeks at a time) for ocular medications or had disease(s), that in the judgment of the examining physician, were vision threatening or might affect the primary outcome (artificial tears were permitted).
• Participant had evidence of classic or occult choroidal neovascularization in either eye, which might include serous RPE detachment, stippling on a fluorescein angiogram, macular edema, evidence of hemorrhage and lipid, and disciform scar.
• Participant had a requirement for acyclovir and/or related products during study duration. To be eligible for this study, the participant had to discontinue use of these products prior to enrollment and could not continue with the products until after they had completed the study.
• Participant had evidence of central serous chorio-retinopathy (CSR) in either eye.
• Participant had evidence of pathologic myopia in either eye.
• Participant had evidence of pseudovitelliform macular degeneration (a dominantly inherited disease characterized by a round or oval yellow subretinal macular deposit) in either eye.
• Participant was receiving systemic steroids or other immunosuppressive medications.
• Participant with evidence of vitreo-retinal traction maculopathy in either eye.
• Participant had a history of laser, photodynamic therapy (PDT), intravitreal injection of antivascular endothelial growth factor (VEGF) agent, or any previous treatment for AMD other than AREDS or equivalent supplement formulation.
• Prior history of vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty.
• Participant had any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 3, or a nuclear opacity > standard 3 as measured on the AREDS clinical lens grading system.
• Participant had undergone lens removal in the last 3 months.
• Participant had participated in any other clinical trial of a drug or within the last 6 months.
• Participant was on chemotherapy.
• Participant was on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
• Participant was pregnant or lactating.
• Participant had other retinal disease(s).
• Participant had a history of malignancy, except study participants with a history of successfully treated cancer (≥5 years prior to inclusion in the trial).
• Participant was considered immunodeficient or had a known history of HIV.
• Participant with a history of ocular herpes zoster.
• Participant's fellow eye visual acuity worse than 20/400.
• Participant had undergone LASIK surgery or other refractive surgery for either eye in less than 6 months prior to screening.
• Participants with severe hearing disabilities in both ears.
• Participants with unmanaged diabetes, patients with CME, or retinopathy in either eye.
• Participant had a history of retinal detachment in either eye.
• Participant who had been diagnosed and treated for amblyopia as an infant.
• Participant with a history of Pars Plana Vitrectomy.