Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children

NCT ID: NCT06742268

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-07-30

Brief Summary

The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.

Detailed Description

Myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. However, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. Since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia.

This multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (SAT-001-KP-002) that evaluated SAT-001, a Software as a Medical Device (SaMD) designed to slow myopia progression in pediatric patients. The current study aims to assess the rebound effect and long-term safety of SAT-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. A total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. Participants from the previous trial who had less than 70% compliance will be excluded from this study. Both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. The primary endpoint is the change in cycloplegic spherical equivalent refractive error (SER) from baseline to 24 weeks, while secondary endpoints include changes in SER at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.

Conditions

Myopia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Arm 1: Spectacles with Cessation of SAT-001 Use

This group consists of pediatric participants who were previously assigned to receive SAT-001 along with single vision spectacles as part of the SAT-001 confirmatory trial (SAT-001-KP-002). In the extension phase, these participants will continue wearing single vision spectacles, but will no longer receive SAT-001 treatment. The aim is to monitor rebound myopia and long-term safety after the completion of the initial trial, focusing on any changes in refractive error and axial length, as well as any adverse effects associated with the cessation of SAT-001 use.

Single vision spectacles

Intervention Type: OTHER

Other interventions for myopia treatment, except for glasses, will not be provided.

Arm 2: Continued Spectacles Only

This group consists of pediatric participants who were assigned to the control group during the SAT-001 confirmatory trial and received only single vision spectacles. In the extension phase, they will continue wearing spectacles to assess rebound myopia and long-term safety, without the addition of SAT-001 treatment.

Single vision spectacles

Intervention Type: OTHER

Other interventions for myopia treatment, except for glasses, will not be provided.

Interventions

Single vision spectacles

Other interventions for myopia treatment, except for glasses, will not be provided.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants who have completed the previous clinical trial (SAT001-KP-002), and their legal guardians who agree to participate in this extension study and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion Criteria

• Participants in the study group of the previous clinical trial (SAT001-KP-002) with a compliance rate of less than 70% (overall compliance throughout the study period).
• Other reasons for participation in the trial at the discretion of the investigator

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paik, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul Asan Medical Center

Han, MD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Kim, MD

Role: PRINCIPAL_INVESTIGATOR

HanGil Eye Hospital

Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Gwang Myeong Hospital

Park, MD

Role: PRINCIPAL_INVESTIGATOR

Daegu Fatima Hospital

Rhiu, MD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Dongtan Sacred Heart Hospital

Locations

Kangbuk Samsung Hospital

Seoul, Choose One..., South Korea

Site Status: RECRUITING

Seoul Asan Medical Center

Seoul, Choose One..., South Korea

Site Status: NOT_YET_RECRUITING

Hallym University Dongtan Sacred heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Chung-Ang University Gwang Myeong Hospital

Gwangmyeong, , South Korea

Site Status: NOT_YET_RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jihye Lee, MSc

Role: CONTACT

sophie@salphadtx.com

(+82) 2-3487-3923

Facility Contacts

Han, MD

Role: primary

Lee, MD

Role: primary

Rhiu, MD

Role: primary

Kim, MD

Role: primary

Baik, MD

Role: primary

Other Identifiers

SAT001-KP-003

Identifier Type: -

Identifier Source: org_study_id