Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-02 @ 8:48 AM
Study NCT ID:
NCT06742268
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in spherical equivalent refractive error', 'timeFrame': 'baseline, 24 weeks', 'description': 'change in spherical equivalent refractive error at 24 weeks from baseline'}], 'secondaryOutcomes': [{'measure': 'change in spherical equivalent refractive error', 'timeFrame': 'Baseline, 12 weeks, 24 weeks', 'description': 'change in spherical equivalent refractive error at 12- and 24-week from baseline'}, {'measure': 'change in axial length', 'timeFrame': 'Baseline, 12 weeks, 24 weeks', 'description': 'change in axial length at 12-week and 24-week from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia', 'Rebound effect', 'SaMD'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n\nExclusion Criteria:\n\n* 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).\n* Other reasons for participation in the trial at the discretion of the investigator'}, 'identificationModule': {'nctId': 'NCT06742268', 'briefTitle': 'Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'S-Alpha Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SAT001-KP-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1: Spectacles with Cessation of SAT-001 Use', 'description': '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.', 'interventionNames': ['Other: Single vision spectacles']}, {'label': 'Arm 2: Continued Spectacles Only', 'description': '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.', 'interventionNames': ['Other: Single vision spectacles']}], 'interventions': [{'name': 'Single vision spectacles', 'type': 'OTHER', 'description': 'Other interventions for myopia treatment, except for glasses, will not be provided.', 'armGroupLabels': ['Arm 1: Spectacles with Cessation of SAT-001 Use', 'Arm 2: Continued Spectacles Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01757', 'city': 'Seoul', 'state': 'Choose One...', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Han, MD', 'role': 'CONTACT'}, {'name': 'Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Choose One...', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Lee, MD', 'role': 'CONTACT'}, {'name': 'Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Hwaseong-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Rhiu, MD', 'role': 'CONTACT'}, {'name': 'Rhiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Dongtan Sacred heart Hospital', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '14323', 'city': 'Gwangmyeong', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kim, MD', 'role': 'CONTACT'}, {'name': 'Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Gwang Myeong Hospital', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'zip': '42724', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Baik, MD', 'role': 'CONTACT'}, {'name': 'Baik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Jihye Lee, MSc', 'role': 'CONTACT', 'email': 'sophie@salphadtx.com', 'phone': '(+82) 2-3487-3923'}], 'overallOfficials': [{'name': 'Paik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}, {'name': 'Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Asan Medical Center'}, {'name': 'Han, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}, {'name': 'Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HanGil Eye Hospital'}, {'name': 'Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang University Gwang Myeong Hospital'}, {'name': 'Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Fatima Hospital'}, {'name': 'Rhiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Dongtan Sacred Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S-Alpha Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}