UnknownEarly Phase 1

Treatment of RP and LCA by Primary RPE Transplantation

China30 participantsStarted 2018-08-01

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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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).

What they're measuring

best-corrected visual acuity (BCVA)

Timeframe: 12 months

Trial details

NCT IDNCT03566147

SponsorEyecure Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-31

Contact for this trial

Jingxue Zhang, Dr

86-18610772626 jingxuezh@163.com

View on ClinicalTrials.gov More Leber Congenital Amaurosis, Retinitis Pigmentosa trials