Degenerative Myopia With Macular Hole Clinical Trial
Official title:
Clinical Research of Human Retinal Pigment Epithelial (HuRPE) Cell Injection on Atrophy of High Myopia Macular Area
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).
| Status | Not yet recruiting |
| Enrollment | 9 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Eyecure Therapeutics Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | six months following transplantation | |
| Secondary | 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. | six months following transplantation | |
| Secondary | 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. | six months following transplantation | |
| Secondary | 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. | six months following transplantation |