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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Chinese Academy of Sciences
Sponsor:
Collaborator:
Beijing Tongren Hospital
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT02755428
First received: March 26, 2016
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
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.

Condition Phase
Nonexudative Age-related Macular Degeneration
Phase 0

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • Number of subjects with adverse events such as the evidence of graft failure or rejection [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10
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)
Groups/Cohorts
Subretinal transplantation
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone aged 55-70 years,who with dry AMD.
Criteria

Inclusion Criteria:

  • Aged 55-70 ys;
  • Diagnosed as atrophic age-related macular degeneration;
  • No CNV;
  • The BCVA of target eye will not be better than 20/400;
  • Diopter is greater than 8.00 D, axial length ≤28 mm;

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02755428

Contacts
Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn

Locations
China, Beijing
Beijing Tongren Hospitol,Capital Medical University Recruiting
Beijing, Beijing, China, 100730
Contact: Wei Wen bin, Doctor    +86-01058265736    weiwenbintr@163.com   
Contact: Yan Yan ni, Doctor    +86-01058269804    ynyan1988@sina.com   
Sponsors and Collaborators
Chinese Academy of Sciences
Beijing Tongren Hospital
Investigators
Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese academy of sciences
  More Information

Responsible Party: Qi Zhou, The vice President and deputy director of Institute of zoology, chinese academy of sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02755428     History of Changes
Other Study ID Numbers: ChineseASZQ-001 
Study First Received: March 26, 2016
Last Updated: April 26, 2016
Health Authority: China:Beijing Municipal Commission of Health and Family Planning

Additional relevant MeSH terms:
Geographic Atrophy
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on April 27, 2016