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Trial record 9 of 243 for:    macular degeneration | Recruiting, Not yet recruiting, Available Studies

Subretinal Transplantation of Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02755428
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

March 26, 2016
April 28, 2016
April 7, 2017
April 2017
June 2018   (Final data collection date for primary outcome measure)
safety and tolerance of transplantation [ Time Frame: one year ]
The safety and tolerance of transplantation of clinical grade 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.
Number of subjects with adverse events such as the evidence of graft failure or rejection [ Time Frame: one year ]
Complete list of historical versions of study NCT02755428 on ClinicalTrials.gov Archive Site
  • Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) [ Time Frame: one year ]
    Visual function measure: change in visual acuity
  • Efficacy:Best corrected visual acuity(BCVA) [ Time Frame: one year ]
    Visual function measure: change in visual acuity
  • Efficacy:Optical coherent tomography (OCT) [ Time Frame: one year ]
    Transplant and host retina integrity and survival
  • Efficacy:fundus autofluorescence [ Time Frame: one year ]
    Transplant and host retina integrity and survival
Same as current
Not Provided
Not Provided
 
Subretinal Transplantation of Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases
Safety and Efficacy of Subretinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Age-related Macular Degeneration Diseases
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD.

This project intends to transplant 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.

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Other
Dry Age-related Macular Degeneration
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).
Experimental: retinal pigment epithelium transplantation
Subretinal transplantation of human embryonic stem cell derived retinal pigment epitheliums.
Intervention: Biological: retinal pigment epithelium transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2020
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 55-75 years;
  • Diagnosed as atrophic age-related macular degeneration;
  • No CNV;
  • The BCVA of target eye will not be better than 20/200;
  • Diopter is smaller than -8.00 D, axial length ≤28 mm;
  • voluntary as test subjects, signed informed consent, regular follow-up on time.

Exclusion Criteria:

  • The macular atrophy caused by other diseases in addition to AMD;
  • With history of other eye diseases or ocular traumas;
  • With history of intraocular surgery;
  • With serious system diseases, ALT/AST)> 1.5 or creatine > 1.3 mg/dL;
  • With any immunodeficiency disease;
  • Subject who are receiving immunosuppressive therapy;
  • Allergic to tacrolimus or Mycophenolate mofetil;
Sexes Eligible for Study: All
55 Years to 75 Years   (Adult, Senior)
No
Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn
China
 
 
NCT02755428
ChineseASZQ-001
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Qi Zhou, Chinese Academy of Sciences
Chinese Academy of Sciences
Beijing Tongren Hospital
Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences
Chinese Academy of Sciences
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP