Subretinal Transplantation of Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases|
- Number of subjects with adverse events such as the evidence of graft failure or rejection [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) [ Time Frame: one year ] [ Designated as safety issue: No ]Visual function measure: change in visual acuity
- Efficacy：Best corrected visual acuity（BCVA） [ Time Frame: one year ] [ Designated as safety issue: No ]Visual function measure: change in visual acuity
- Efficacy：Optical coherent tomography (OCT) [ Time Frame: one year ] [ Designated as safety issue: No ]Transplant and host retina integrity and survival
- Efficacy：fundus autofluorescence [ Time Frame: one year ] [ Designated as safety issue: No ]Transplant and host retina integrity and survival
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
This project intends to transplant the clinical level human embryonic stem cells derived retinal pigment epitheliums into subretinal space to treat age-related macular degeneration(AMD).
Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety of RPE transplants to treat AMD disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02755428
|Contact: Wang Liu, Doctoremail@example.com|
|Contact: Hao Jie, Doctorfirstname.lastname@example.org|
|Beijing Tongren Hospitol,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Wei Wen bin, Doctor +86-01058265736 email@example.com|
|Contact: Yan Yan ni, Doctor +86-01058269804 firstname.lastname@example.org|
|Principal Investigator:||Zhou Qi, Doctor||Institute of zoology, Chinese academy of sciences|