A Study to Determine the Safety and Efficacy of NT-501 With MHFM

Exclusion Criteria

• •1. Subject is medically unable to comply with study procedures or follow-up visits.
• •2. Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
• •3. Subject has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye OR has, within the past 3 months, received intravitreal anti-VEGF therapy in the fellow eye at randomization.
• •4. Subject has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (e.g., uncontrolled glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis).
• •6. Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
• •7. Subject has evidence of intraretinal hyperreflectivity by OCT.
• •8. Subject has evidence of central serous chorio-retinopathy in either eye.
• •9. Subject has evidence of pathologic myopia in either eye.
• •10. Subject has significant corneal or media opacities in either eye.
• •11. Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
• •12. Subject has any of the following lens opacities: 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.
• •13. Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
• •14. Previous participation in any Neurotech MacTel clinical trial unless the participant previously consented and screened for either the NTMT-03A or NTMT-03B study and were deemed a screen failure solely due to small lesion size.
• •15. Subject was a participant in any other ocular related or ocular impacted clinical trial of an intervention (drug or device) within the last 6 months.
• •16. Subject is on chemotherapy.
• •17. Subject is pregnant or breastfeeding.
• •18. Subject has a history of malignancy that would compromise the 12-month study survival.
• •19. Subject with a history of ocular herpes virus in either eye.
• •20. Subject 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.
• •21. Subject has evidence of subfoveal RPE hyperplasia.