Macular Degeneration Clinical Trial
Official title:
Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients
Early Phase I Study of the Safety and Preliminary Efficacy of Human Fetal Retinal Pigment Epithelial(fRPE) Cells Subretinal Transplantation in Age-Related Macular Degeneration(AMD) Patients
This study is a perspective, single-arm and open-labeled investigation of the safety and
preliminary efficacy of unilateral subretinal transplantation of fRPE cells in subjects with
dry Age-Related Macular Degeneration and non-exudative AMD. The investigators will recruit
and enroll 6 patients based on specific inclusive/exclusive criteria. Experimental and
self-controlled eye will be determined based on best-corrected visual acuity (BCVA). The eye
with BCVA of no more than 20/400 will be determined as experimental eye, which will be
divided into 3 groups and undergo subretinal injection of 3 different dosages of fRPE cells
(100.000, 200,000 or 500,000) respectively, while the other one (BCVA of more than or equal
to 20/400) as control eye, will not receive the surgery.
fRPE cells will be obtained from the fetuses aborted in the Department of Obstetrics and
Gynecology in Jiangsu Province Hospital from 2015 to 2018. The obtained fRPE cells will meet
specific inclusive/exclusive criteria and conform to Good manufacturing practices (GMP).
fRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be
administered into the subretinal space of experimental eye through a standard surgical
approach.
Immunosuppressive agents will be administered orally to all subjects after transplantation.
Dosage and time duration of immunosuppressive agents will be regulated strictly relying on
the condition of immune rejection. Subjects will be monitored with ophthalmologic and
systemic examinations frequently at regular post-transplant intervals after fRPE cell
transplantation.
;
| 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 | |
| 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 | |
| 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 | |
| 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 |