Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration
Age-Related Macular Degeneration
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria: 1. Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria: a. Previously received IVT treatment of anti-VEGF for neovascular AMD, with documented response to anti-VEGF therapy during the first 2 weeks of screening b. active macular CNV lesion secondary to AMD evidenced by SD-OCT c. Have a ETDRS BCVA letter score of 63 to 19 (approximately 20/63 to 20/400 Snellen equivalent) in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 19 (approximately 20/40 to 20/400 Snellen equivalent) for the rest of the subjects each cohort; d. Pseudophakia in the study eye, with ocular media to permit high quality fundus imaging at screening and allow planned vitrectomy and subretinal injection; e. Are willing and able to sign the study written informed consent form (ICF). Exclusion Criteria: Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF Retinal pigment epithelial tears or rips at screening Any history or presence of vitreous hemorrhage; Have any condition preventing visual acuity improvement; Have any other cause of CNV; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, Epiretinal membrane or vitreo-macular traction; full thickness macular hole; History of intraocular or periocular surgery in the prior 3 months; Prior trabeculectomy or other filtration surgery ; Any use of long-acting intraocular steroids, including implants, within six months prior;
Sites / Locations
- Kanghong Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
KH631 Dose 1
KH631 Dose 2
KH631 Dose 3
KH631 Dose 4
KH631 Dose 5
KH631 One-Time Intraocular Injection Dose Level 1
KH631 One-Time Intraocular Injection Dose Level 2
KH631 One-Time Intraocular Injection Dose Level 3
KH631 One-Time Intraocular Injection Dose Level 4
KH631 One-Time Intraocular Injection Dose Level 5