Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-07 @ 8:21 AM
Study NCT ID:
NCT05639660
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Implication of Aflibercept in PCV Treatment in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092342', 'term': 'Polypoidal Choroidal Vasculopathy'}], 'ancestors': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Mean BCVA from baseline at the month 3, 6, 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'Routine International standard visual acuity chart, best corrected visual acuity'}, {'measure': 'Mean treatment pattern of aflibercept in PCV treatment', 'timeFrame': 'Through study completion, 1 year', 'description': 'To describe the mean treatment pattern of aflibercept in PCV treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with each treatment regimen', 'timeFrame': 'Through study completion, 1 year', 'description': "based on different count and describe the patients' proportion"}, {'measure': 'Change in CRT from baseline at month 3, 6, 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'Non-contact intraocular pressure before and after study eye injection, study eye slit lamp, ophthalmoscopy, identify the change of CRT'}, {'measure': 'Proportion of patients with complete regression of polyps at month 3, 6, 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'color fundus photography of the research eye, study eye ICGA angiography'}, {'measure': 'Proportion of patients with inactivity polyps at month 3, 6, 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'color fundus photography of the research eye, study eye ICGA angiography'}, {'measure': 'Proportion of patients with dry retina at month 3, 6 and 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'OCT, OCTA examination, color fundus photography of the research eye'}, {'measure': 'Proportion of patients with PED regression at month 3, 6 and 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'OCT, OCTA examination'}, {'measure': 'Mean of treatment interval and number of injections at month 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'Observe and describe the treatment pattern during routine follow-up visits'}, {'measure': 'Inactive polyp evaluation by OCTA at month 3, 6, 12', 'timeFrame': 'Through study completion, 1 year', 'description': 'OCTA examination during follow-up visits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polypoidal Choroidal Vasculopathy', 'Aflibercept'], 'conditions': ['Polypoidal Choroidal Vasculopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.\n\nMain evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.', 'detailedDescription': "Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)\n\n1. To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.\n2. To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)\n3. To explore the relative factors of aflibercept treatment effectiveness.\n4. To describe patients' tolerance to anti-VEGF and PDT treatment.\n5. To collect safety information with aflibercept treatment in a wider population setting"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed as polypoid choroidal vasculopathy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years, gender, unilateral or bilateral onset\n2. Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination\n3. Signed informed consent, able to long-term follow-up\n4. PCV patients previously treated with aflibercept were enrolled as retrospective cases, and PCV patients previously treated with other anti-VEGF, at least 1 month since the last treatment\n\nExclusion Criteria:\n\n1. Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma\n2. Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit\n3. The study eye has a history of idiopathic or autoimmune uveitis\n4. Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis\n5. The patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.\n6. The patient is receiving treatment for severe systemic infection\n7. Patients with uncontrolled blood pressure (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg when the subject is sitting)\n8. Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visit\n9. Patients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantation\n10. The investigator believes that based on the history of other diseases, metabolic dysfunction, physical examination results or clinical laboratory results, patients have a disease or condition that will increase the risk for complications from treatment\n11. Pregnant or lactating women; women of childbearing potential with positive pregnancy test results at baseline or not receiving pregnancy test; postmenopausal women must have been amenorrhea for at least 12 months to not be considered fertile\n12. Participated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visit\n13. The patient has received other anti-VEGF therapy within 30 days\n14. Other patients deemed necessary to be excluded by the investigator'}, 'identificationModule': {'nctId': 'NCT05639660', 'briefTitle': 'Clinical Implication of Aflibercept in PCV Treatment in China', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study', 'orgStudyIdInfo': {'id': 'CAPTAIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aflibercept group', 'description': 'Single arm, Aflibercept 2.0mg/0.05ml, intravitreal injection', 'interventionNames': ['Other: non-interventional']}], 'interventions': [{'name': 'non-interventional', 'type': 'OTHER', 'description': "The treatment guideline recommends the 3+Q2m regimen for Aflibercept, but this study is an observational study, no intervention is made in the subjects' treatment regimen. There is no prescribed visit plan. According to the decision of the doctor and the patient according to the treatment plan, the patient needs to come to the clinic within the prescribed time window (3, 6, and 12 months) to facilitate the recording of data.", 'armGroupLabels': ['Aflibercept group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Youxin, Professor', 'role': 'CONTACT', 'email': 'chenyouxinpumch@163.com', 'phone': '010-69156114'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Youxin Chen, Professor', 'role': 'CONTACT', 'email': 'chenyx@pumch.cn', 'phone': '+86 13801025972'}], 'overallOfficials': [{'name': 'Youxin Chen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}