Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)

Status: Active_not_recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy. The main question it aims to answer are: • Percentage of changes in the chorioretinal atrophic area Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare non-therapeutic eye to see if the changes is significant different.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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) or patients 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 60 characters (equivalent to decimal visual acuity 0.32)

• Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary 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

Locations
Other Locations
Japan
Nagoya city university hospital
Nagoya
Time Frame
Start Date: 2023-02-17
Completion Date: 2026-03-31
Participants
Target number of participants: 10
Treatments
Experimental: therapeutic group
Related Therapeutic Areas
Sponsors
Leads: PharmaBio Corporation

This content was sourced from clinicaltrials.gov