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).
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.
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