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Status unknownNCT04212624Updated Dec 27, 2019

Clinical Research of Human Retinal Pigment Epithelial (HuRPE) Cell Injection on Atrophy of High Myopia Macular Area

An interventional study of Human retinal pigment epithelial (HuRPE) cell injection in Degenerative Myopia With Macular Hole, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-27.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and tolerability of human retinal pigment epithelial (HuRPE) cell injection subretinal transplantation for atrophy of high myopia macular area, and to explore the maximum tolerated dose (MTD).

Read the detailed description

This study is a perspective, single-arm and open-labeled investigation of the safety and preliminary efficacy of unilateral subretinal transplantation of HuRPE cells in subjects with Macular degeneration caused by high myopia. The investigators will recruit and enroll 9 patients based on specific inclusive/exclusive criteria. Experimental and self-controlled eye will be determined based on best-corrected visual acuity (BCVA). The eye with BCVA between 5 and 60 ETDRS letters will be determined as experimental eye, which will be divided into 3 groups and undergo subretinal injection of 3 different dosages of HuRPE cells (300.000, 500,000 or 1,000,000) respectively, while the other one as control eye, will not receive the surgery.

HuRPE cells will be obtained from Eyecure Therapeutics, Inc.(Jiangsu) located in WuXi, Jiangsu Province. The obtained HuRPE cells will meet its quality standards and conform to Good manufacturing practices (GMP). HuRPE cells 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.

Immunosuppressive agents will be administered orally to all subjects after transplantation. Dosage and time duration of immunosuppressive agents will be regulated strictly relying on the condition of immune rejection. Subjects will be monitored with ophthalmologic and systemic examinations frequently at regular post-transplant intervals after HuRPE cells transplantation.

02

Conditions studied

  • Degenerative Myopia With Macular Hole

Keywords

  • Human retinal pigment epithelial (HuRPE) cell injection
  • High myopia
  • retinal degeneration
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 9 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. A patient who is able (or with the assistance of his or her legal representative) to read and understand the informed consent form and is willing to sign a written informed consent;
  2. age ≥ 18 years old, male or female;
  3. myopic diopter ≥ -6D or visual axis length ≥ 26mm;
  4. study the best corrected visual acuity ≥ 5 letters, ≤ 60 letters (using ETDRS eye chart);
  5. According to the researcher's judgment, the patient's high myopia macular atrophy is the main reason for the patient's vision loss;
  6. If both eyes meet the inclusion criteria, the selected disease is more severe; the eyes are the same, and the right eye is the study eye.

Exclusion criteria

Exclusion Criteria:

  1. The study eye has intravitreal hemorrhage within 2 months before the group visit;
  2. the study of the eye involved in the foveal scar, fibrosis, suggesting a serious irreversible vision loss;
  3. The study eye diagnosis is a pupillary afferent defect (APD);
  4. the study eye has significant refractive interstitial opacity, and moderate to severe cataract, may cause interference to OCT and fundus examination;
  5. any eye diagnosed as infectious blepharitis, keratitis, scleritis or conjunctivitis; or there are currently serious systemic infectious diseases;
  6. Uncontrollable glaucoma, defined as a patient who is adequately treated with medication, with an intraocular pressure still above 25 mmHg, or who has undergone previous or filtering surgery;
  7. Study the eye with other diseases that affect vision;
  8. traumatic macular hole, idiopathic macular hole, combined with other parts of the retinal tear;
  9. single eye blind patients;
  10. The study eye is an aphakic eye (except for the intraocular lens);
  11. Any eye has a history of idiopathic or autoimmune-related uveitis;
  12. Any eye is diagnosed as an iris neovascularization;
  13. Received cataract surgery within 2 months prior to enrollment;
  14. Other intraocular surgery was performed within 3 months prior to the group visit;
  15. Have an allergic reaction or allergic history to sodium fluorescein, a history of allergies to protein products for therapeutic or diagnostic use, and allergies to two or more drugs and/or non-drug factors, or those with allergic diseases;
  16. Diabetes patients with uncontrolled blood glucose (fasting blood glucose ≥7.0mmol/L or 2h postprandial blood glucose ≥11.1mmol/L);
  17. There is a history of surgery within 1 month before screening, or there are currently unhealed wounds, ulcers, fractures, etc.;
  18. patients with uncontrolled hypertension, defined as the best treatment plan, a single measurement of systolic blood pressure > 180mmHg, two consecutive measurements of systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg;
  19. History of myocardial infarction within 6 months prior to enrollment;
  20. There is active diffuse intravascular coagulation or obvious bleeding tendency before screening. Anticoagulation or anti-platelet aggregation drugs are used in addition to aspirin/non-steroidal anti-inflammatory drugs within 14 days before screening;
  21. Any clinical problem that cannot be controlled (such as severe mental, neurological, cardiovascular, respiratory, malignant, Parkinson's, Alzheimer's disease, etc.);
  22. Women of childbearing age were positive in the screening visit pregnancy test. Women who wish to breastfeed during the study. All women of childbearing age (male and female) did not agree to take effective contraceptive measures (such as intrauterine devices, birth control pills or condoms) during the entire study period and within 30 days of the end of the visit period;
  23. Patients who participated or are currently participating in other clinical studies within 30 days prior to screening;
  24. Hemoglobin \<100 g/L, blood Plt≤100×109/L, neutrophil count \<1.0×109/L, ALT/AST> upper limit of normal value (ULN)×1.5, Cr>1.3 mg/dL;
  25. Researchers believe that patients who are not eligible for inclusion, or other medical conditions, limit subject compliance, safety, or impact study results.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    test arm

    The 25G or 23G conjunctival seamless vitrectomy was performed on the anterior eye to remove the anterior-posterior direction and tangential direction of the rupture hole. The area outside the macular foveal lesion was selected, but 100 μl of HuRPE cell injection was injected within about 2 PD. In combination with the Medone syringe and the combined 35G or 37G needle, the silicone oil injection module is used for injection, and the injection is performed in an amount of 100 μl (depending on the cell concentration). The doses of the three dose groups from low to high were 300,000 cells, 500,000 cells, and 1 million cells, respectively, in a single injection.

    Other: Human retinal pigment epithelial (HuRPE) cell injection

Interventions

  • OtherHuman retinal pigment epithelial (HuRPE) cell injection

    Human retinal pigment epithelial cell injection Dosage form and specifications: injection; 600,000 cells / branch (200μl), 1 million cells / branch (200μl), 2 million cells / branch (200μl) Transportation and storage: sealed, stored at 2-8 ° C, valid for 6 hours

06

What researchers measure

Primary outcomes

  1. Number of subjects with Local and systemic adverse events

    Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period.

    Time frame: six months following transplantation

Secondary outcomes

  1. Mean change of Best-Corrected Visual Acuity (BCVA)

    Best-corrected visual acuity (BCVA) will be assessed in a sitting position using manifest refraction and ETDRS-like visual acuity testing charts. higher scores means improvement of patient's visual acuity.

    Time frame: six months following transplantation

  2. Evidence of successful engraftment

    Structural evidence (OCT imaging, fluorescein angiography, slit-lamp examination with fundus photography) that HuRPE cells have been implanted in the correct location.

    Time frame: six months following transplantation

  3. Change in NEI VFQ-25 Total Score

    National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the "NEI VFQ-25 Scoring Algorithm - August 2000". The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.

    Time frame: six months following transplantation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04212624
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Eyecure Therapeutics Inc.
Responsible party
Xiaodong Sun (Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Dec 27, 2019
Start date
Dec 2019 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Dec 27, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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