Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants

Exclusion Criteria

• •1. Participant is medically unable to comply with clinical study procedures or visits.
• •2. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
• •3. Participant has significant corneal or media opacities in the study eye to be implanted.
• •4. Participant has evidence of pathologic myopia in the study eye to be implanted.
• •5. Participant has any of the following lens opacities in the study eye to be implanted: cortical opacity \> standard 3, posterior subcapsular opacity \> standard 2, or a nuclear opacity \> standard 3 as measured on the Age- Related Eye Disease Study (AREDS) clinical lens grading system. Note: the participant can be reconsidered for enrollment 90 days after undergoing cataract surgery.
• •6. Participant has undergone lens removal in the study eye to be implanted in the previous 3 months or YAG laser within 4 weeks of the screening/baseline visit.
• •7. Participant has evidence of ocular disease in the study eye to be implanted other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (eg. glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis).
• •8. Received intravitreal steroid therapy in the study eye to be implanted within the last year.
• •9. Received intravitreal anti-vascular endothelial growth factor therapy in the study eye to be implanted within the last 6 months.
• •10. Evidence of active exudative intraretinal neovascularization or subretinal neovascularization in the study eye to be implanted, as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid.
• •11. Evidence of central serous chorioretinopathy in the study eye to be implanted.
• •12. Participant underwent vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty in the study eye to be implanted.
• •13. A history of ocular herpes virus in the study eye to be implanted.
• •14. Participant is on chemotherapy.
• •15. Participant is pregnant or breastfeeding.
• •16. Participation in any other clinical study of an intervention (drug or device) within 6 months prior to the screening/baseline visit.
• •17. A history of malignancy that would compromise survival during the clinical study.