Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07235527
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Best-Corrected Visual Acuity (BCVA) and Central Macular Thickness After MY-1701P Injection', 'timeFrame': 'Baseline to Month 6', 'description': 'Evaluation of anatomical and functional outcomes following intravitreal MY-1701P (aflibercept biosimilar) treatment, including presence or resolution of intraretinal and subretinal fluid, changes in central macular thickness, and improvement in best-corrected visual acuity (BCVA) measured by standardized ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen methods.'}], 'secondaryOutcomes': [{'measure': 'Effect of MY-1701P on Pigment Epithelial Detachment, Neovascularization Size, and Treatment Interval Adjustment', 'timeFrame': 'Baseline to Month 6', 'description': 'Assessment of the influence of MY-1701P treatment on pigment epithelial detachment (PED) height and area, macular neovascularization size, and changes in treatment intervals over the follow-up period, based on optical coherence tomography (OCT) and fluorescein angiography findings.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['age related macular degeneration', 'anti vascular endothelial growth factor', 'anti-VEGF', 'aflibercept', 'macular neovascularization', 'aflibercept biosimilar'], 'conditions': ['Age Related Macular Degeneration', 'Exudative Age-Related Macular Degeneration', 'Anti Vascular Endothelial Growth Factor']}, 'descriptionModule': {'briefSummary': 'In this study, patients receiving Eylea treatment will be treated with Yesafili, a biosimilar molecule, and routine examination results will be noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 45 to 90 years diagnosed with active neovascular (exudative) age-related macular degeneration (nAMD), who are receiving routine ophthalmologic follow-up at a tertiary referral center and have been clinically indicated for intravitreal aflibercept biosimilar (MY-1701P) injection. Participants will be selected based on evidence of disease activity on ophthalmologic examination and optical coherence tomography (OCT) imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 45 and 90 years with active neovascular age-related macular degeneration (nAMD)\n* who show signs of disease activity on routine ophthalmologic examination and optical coherence tomography (OCT)\n* for whom intravitreal injection has already been clinically indicated\n\nExclusion Criteria:\n\n* Patients younger than 45 years or older than 90 years\n* History of stroke, cerebrovascular event, myocardial infarction, or coronary stent placement within the last six months\n* Presence of uveitis\n* Media opacity preventing adequate retinal imaging (e.g., corneal opacity, mature cataract)\n* Coexistence of other retinal vascular diseases (e.g., branch retinal vein occlusion, diabetic macular edema)\n* Presence of hereditary retinal dystrophies\n* Presence of optic atrophy'}, 'identificationModule': {'nctId': 'NCT07235527', 'briefTitle': 'Real-Life Clinical Outcomes of Aflibercept Biosimilar MY-1701P in the Treatment of Exudative Age-Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Real-World Outcomes of Aflibercept Biosimilar MY-1701P Treatment in Exudative Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'skalpakoglu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients treated with Yesafili', 'description': 'aflibercept biosimilar used', 'interventionNames': ['Drug: Aflibercept biosimilar (MY-1701P)']}], 'interventions': [{'name': 'Aflibercept biosimilar (MY-1701P)', 'type': 'DRUG', 'description': 'Patients receiving the aflibercept biosimilar MY-1701P (marketed as Yesafili®) as part of routine clinical care.', 'armGroupLabels': ['patients treated with Yesafili']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'state': 'şişli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sinan Kalpakoğlu, m.d.', 'role': 'CONTACT', 'email': 'sinankalpakoglu17@gmail.com', 'phone': '+905380518244'}], 'facility': 'Prof. Dr. Cemil Taşcıoğlu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sinan Kalpakoğlu, M.D.', 'role': 'CONTACT', 'email': 'sinankalpakoglu17@gmail.com', 'phone': '+905380518244'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmology Consultant, Principal Investigator', 'investigatorFullName': 'Sinan KALPAKOĞLU, MD', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}