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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.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Leber Congenital Amaurosis, Retinitis Pigmentosa Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Experimental: low dose group
300,000 HuRPE cells
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: middle dose group
500,000 HuRPE cells
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: high dose group
1,000,000 HuRPE cells
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.




Primary Outcome Measures :
  1. best-corrected visual acuity (BCVA) [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Eyecure Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03566147     History of Changes
Other Study ID Numbers: TR-RPE-RP/LCA
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Blindness
Leber Congenital Amaurosis
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms