Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
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|ClinicalTrials.gov Identifier: NCT05658237|
Recruitment Status : Recruiting
First Posted : December 20, 2022
Last Update Posted : March 20, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Myopic Chorioretinal Atrophy||Procedure: Pars plana vitrectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)|
|Actual Study Start Date :||February 17, 2023|
|Estimated Primary Completion Date :||August 31, 2024|
|Estimated Study Completion Date :||October 31, 2024|
|Experimental: therapeutic group||
Procedure: Pars plana vitrectomy
One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
- Percentage of changes in the chorioretinal atrophic area [ Time Frame: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks ]Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05658237
|Contact: Toshihiko Sugioka||+81 firstname.lastname@example.org|
|Nagoya city university hospital||Recruiting|
|Nagoya, Aichi, Japan|
|Study Director:||Hitoshi Kusano, M.D.||PhamaBio Coorporation|