Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells
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|ClinicalTrials.gov Identifier: NCT03046407|
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dry Age-related Macular Degeneration||Biological: retinal pigment epithelium transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: retinal pigment epithelium transplantation
transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
Biological: retinal pigment epithelium transplantation
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
- safety and tolerance of transplantation [ Time Frame: 12 months ]The safety and tolerance of transplantation of hESC-derived RPE will be considered safe: no above moderate adverse events or severe adverse events which related to transplantation of retinal pigment epithelial cells ; Cells without infectious; No tumorigenicity. Through the clinical signs of subjects and laboratory examination to judge the tolerance, integrity, repellency of RPE cells, and monitoring the presence of local or systemic infection, and presence of metastatic tumor cells.
- Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) [ Time Frame: 12 months ]Visual function measure: change in visual acuity
- Efficacy：Best corrected visual acuity（BCVA） [ Time Frame: 12 months ]Visual function measure: change in visual acuity
- Efficacy：Optical coherent tomography (OCT) [ Time Frame: 12 months ]Visual function measure
- Efficacy：fundus autofluorescence [ Time Frame: 12 months ]Transplant and host retina integrity and survival
- Efficacy：vision inspection [ Time Frame: 12 months ]Changes of judgment after transplantation of patient's visual field
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046407
|Contact: Wang Liu, Doctorfirstname.lastname@example.org|
|Contact: Hao Jie, Doctoremail@example.com|
|Principal Investigator:||Zhou Qi, Doctor||Institute of zoology, Chinese Academy of Sciences|