Treatment of RP and LCA by Primary RPE Transplantation

Leber Congenital Amaurosis, Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03566147
• Other study ID #: TR-RPE-RP/LCA
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2018
• Source: Eyecure Therapeutics Inc.
• Contact: Jingxue Zhang, Dr
• Phone: 86-18610772626
• Email: jingxuezh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blindness
• Leber Congenital Amaurosis
• Leber Congenital Amaurosis, Retinitis Pigmentosa
• Retinitis
• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Eyecure Therapeutics Inc.	Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best-corrected visual acuity (BCVA)		12 months