Last updated: January 30, 2024
Sponsor: PharmaBio Corporation
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
Pars plana vitrectomy
Clinical Study ID
NCT05658237
PAL-222-P1
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged 20 years or older at the time of consent acquisition
- Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) orpatients with axial length (26 mm) or more equivalent to -6.0 D
- Corrected characters of the test eye patients with visual acuity of less than 60characters (equivalent to decimal visual acuity 0.32)
- Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm)including the fovea centralis in the subject eye
- Patients without active choroidal neovascularization
Exclusion
Exclusion Criteria:
- Patients with abnormal findings that pose a problem in clinical trial participation inscreening tests.
- Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV)antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction
- Patients with allergies to human serum albumin antibiotics, trypsin
- Patients with eye infections
- Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy,vascular occlusion)
- Patients with confirmed optic nerve atrophy
- Patients with glaucoma who cannot control intraocular pressure
- Patients with findings associated with myopic traction macular disease (apparentposterior macular tumor, vitreous macular traction, retinal separation, macular holedetachment, macular hole)
- Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
- Patients with corrected visual acuity of control eye 0.08 or less
- Patients with severe blood disorders, heart failure, liver disorders, and renaldisorders
- Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
- Pregnant women, lactating women, patients wishing to become pregnant during the trialperiod
- Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
- Patients with drug addiction or alcoholism
- Patients receiving treatment with vascular endothelial growth factor inhibitor orphotodynamic therapy within 4 months prior to transplantation for test eye or 2 monthsfor reference eye.
- Patients who underwent eye surgery (excluding lens reconstruction) within 3 monthsbefore transplantation. In the case of cataract surgery, if 7 days or more have passedsince surgery and postoperative inflammation is stable, registration is possible.
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Pars plana vitrectomy
Phase:
Study Start date:
February 17, 2023
Estimated Completion Date:
March 31, 2026
Connect with a study center
Nagoya city university hospital
Nagoya, Aichi
JapanActive - Recruiting
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