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Clinical Trials/NCT03566147
NCT03566147
Unknown
Early Phase 1

Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation

Eyecure Therapeutics Inc.1 site in 1 country30 target enrollmentStarted: August 1, 2018Last updated:
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ConditionsLeber Congenital Amaurosis, Retinitis Pigmentosa

Overview

Phase
Early Phase 1
Sponsor
Eyecure Therapeutics Inc.
Enrollment
30
Locations
1
Primary Endpoint
best-corrected visual acuity (BCVA)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Blood routine examination is abnormal (hemoglobin\<10gm/dL; blood platelet count\<100k/mm³; neutrophil count\<1000/mm³)
  • •Blood biochemistry is abnormal (ALT／AST\>1.5; creatinine\>1.3mg/dL)
  • •Experimental eye has optic nerve atrophy caused by glaucoma
  • •Experimental eye has retinal detachment, or has received retinal detachment surgery.
  • •Patients with uveitis and other endophthalmitis
  • •Patients with other ocular disease affecting vision.
  • •Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
  • •Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
  • •Patients with medical history of myocardial infarction
  • •Patient with diabetes

Outcomes

Primary Outcomes

best-corrected visual acuity (BCVA)

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eyecure Therapeutics Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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