Clinical trial NCT06742268: Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children
Official title: A Multi-center, Open-label, Controlled Extension Study to Evaluate the Rebound Effect and Long-term Safety of Software SAT-001 for the Inhibition of Myopia Progression and Treatment in Pediatric Patients With Myopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Keywords: Myopia
Rebound effect
SaMD
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of children aged 5 to 8 years at the time of their participation in the previous confirmatory trial (SAT-001-KP-002), who are continuing in the extension study. Participants will remain in their original groups (study or control group) with no new randomization.

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.

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

Primary outcomes:
measure: change in spherical equivalent refractive error
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: change in spherical equivalent refractive error
timeFrame: Baseline, 12 weeks, 24 weeks
measure: change in axial length
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Choose One...
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
state: Choose One...
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred heart Hospital
state: Gyeonggi
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwang Myeong Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Paik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Asan Medical Center
name: Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangbuk Samsung Hospital
name: Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HanGil Eye Hospital
name: Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Gwang Myeong Hospital
name: Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Fatima Hospital
name: Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Sacred heart Hospital
name: Rhiu, MD
role: PRINCIPAL_INVESTIGATOR
References: