Macular Degeneration Clinical Trial
Official title:
Phase I/II Study of the Safety and Preliminary Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration.
This study is an open-label dose-escalation investigation of the safety and preliminary
efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with
Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be
enrolled based on specific inclusion/exclusion criteria and evaluated at regular post
transplant intervals. The investigation will be divided into two sequential cohorts.
Subjects will be enrolled into each cohort based on best-corrected visual acuity (BCVA)
visual acuity as determined by the Electronic Early Treatment Diabetic Retinopathy Study
(E-ETDRS) acuity test. BCVA of less than or equal to 20/400 in the Study Eye will be
enrolled in Cohort I. Subjects with BCVA of 20/320 to 20/100 in the Study Eye will be
enrolled in Cohort II. Cohort I will consist of four subjects who will undergo transplant
with 200,000 cells followed by four subjects who will undergo transplant with 1 million
cells. Cohort II will consist of 7 subjects who will undergo transplant with 1 million
cells. An independent Data Monitoring Committee (DMC) will review accruing safety data for
all subjects.
HuCNS-SC cells will be transplanted by a board-certified vitreoretinal surgeon. The
transplantation will be conducted in the eye with the inferior best-corrected visual acuity
(BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The HuCNS-SC
cells will be administered into the subretinal space through a standard surgical approach.
Immunosuppressive agents will be administered orally to all subjects for a period of three
months after surgery.
Subjects will be monitored frequently for a total of one year after HuCNS-SC cell
transplantation. An additional four years of monitoring will be conducted in a separate
follow-up study that will commence with the termination visit of the Phase I/II
investigation. The follow-up study will be conducted as a separate investigation.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
Completed |
NCT02540954 -
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
|
Phase 3 | |
Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
Completed |
NCT02510794 -
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
|
Phase 2 | |
Terminated |
NCT02228304 -
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Completed |
NCT02181504 -
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT01204541 -
A Single-Center Pilot Study to Assess Macular Function
|
N/A | |
Completed |
NCT00769392 -
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
|
N/A | |
Completed |
NCT00533520 -
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
|
Phase 4 | |
Withdrawn |
NCT00538538 -
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
|
Phase 1 | |
Completed |
NCT00536016 -
A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
|
Phase 1 | |
Terminated |
NCT00403442 -
Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD
|
Phase 1 | |
Recruiting |
NCT00157976 -
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
|
Phase 3 | |
Completed |
NCT00211458 -
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
|
Phase 2 | |
Completed |
NCT00242580 -
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
|
Phase 3 | |
Completed |
NCT00239928 -
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
|
Phase 2 | |
Completed |
NCT00095433 -
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
|
Phase 3 | |
Completed |
NCT00006202 -
Lutein for Age-Related Macular Degeneration
|
Phase 2 |