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Treatment of RP and LCA by Primary RPE Transplantation

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ClinicalTrials.gov Identifier: NCT03566147
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
Tongren Hospital
Information provided by (Responsible Party):
Eyecure Therapeutics Inc.

June 12, 2018
June 21, 2018
June 21, 2018
July 1, 2018
December 31, 2019   (Final data collection date for primary outcome measure)
best-corrected visual acuity (BCVA) [ Time Frame: 12 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of RP and LCA by Primary RPE Transplantation
Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients
Not Provided
Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leber Congenital Amaurosis, Retinitis Pigmentosa
Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE 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.
  • Experimental: low dose group
    300,000 HuRPE cells
    Intervention: Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
  • Experimental: middle dose group
    500,000 HuRPE cells
    Intervention: Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
  • Experimental: high dose group
    1,000,000 HuRPE cells
    Intervention: Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
Same as current
March 31, 2020
December 31, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of RP or LCA;
  2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
  3. Patient understand and sign the consent form.

Exclusion Criteria:

  1. Blood routine examination is abnormal (hemoglobin<10gm/dL; blood platelet count<100k/mm³; neutrophil count<1000/mm³)
  2. Blood biochemistry is abnormal (ALT/AST>1.5; creatinine>1.3mg/dL)
  3. Experimental eye has optic nerve atrophy caused by glaucoma
  4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
  5. Patients with uveitis and other endophthalmitis
  6. Patients with other ocular disease affecting vision.
  7. Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
  8. Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
  9. Patients with medical history of myocardial infarction
  10. Patient with diabetes
  11. Patient with Parkinson disease or Alzheimer's disease
  12. Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
  13. Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Not Provided
 
 
NCT03566147
TR-RPE-RP/LCA
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Eyecure Therapeutics Inc.
Eyecure Therapeutics Inc.
Tongren Hospital
Not Provided
Eyecure Therapeutics Inc.
June 2018

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