Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-02 @ 11:03 AM
Study NCT ID:
NCT04215393
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016510', 'term': 'Corneal Neovascularization'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal 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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2019-12-31', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular and Systemic Safety: occurrence of ocular and systemic adverse events', 'timeFrame': 'day 14', 'description': 'The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations. Systemic adverse events were identified with physical examinations.'}], 'secondaryOutcomes': [{'measure': 'The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study', 'timeFrame': 'day 14 and day 28', 'description': 'The efficacy of KH906 in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Neovascularization']}, 'descriptionModule': {'briefSummary': 'The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.\n\nThe second stage of this study will evaluate the effectiveness of conbercept eye drop initially.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.\n* Ages from 18 to 75,male or female.\n* Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.\n\nExclusion Criteria:\n\n* Subjects who had significant defect in the corneal epithelium.\n* Study eye had been injected of anti-vegf drugs within 3 months before screening\n* Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.\n* Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)\n* Systemic use of anti-vegf drugs within 45 days prior to screening.\n* Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants（except aspirin）.\n* Uncontrolled clinical problems such as canner etc..\n* Unable or unwilling to use effective contraception.\n* Positive blood tests for pregnancy (female subjects)\n* Participated in drug clinical trials within 3 months before the first administration.\n* The researchers think the participants were not suitable for this trail.'}, 'identificationModule': {'nctId': 'NCT04215393', 'briefTitle': 'An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Biotech Co., Ltd.'}, 'officialTitle': 'An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization', 'orgStudyIdInfo': {'id': 'KH906-40101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conbercept eye drop (0.1mg/ mL)', 'description': 'Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.', 'interventionNames': ['Drug: Conbercept eye drop']}, {'type': 'EXPERIMENTAL', 'label': 'Conbercept eye drop (0.5mg/ mL)', 'description': 'Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.', 'interventionNames': ['Drug: Conbercept eye drop', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Conbercept eye drop (1.0mg/ mL)', 'description': 'Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.', 'interventionNames': ['Drug: Conbercept eye drop', 'Drug: Placebo']}], 'interventions': [{'name': 'Conbercept eye drop', 'type': 'DRUG', 'description': 'In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.', 'armGroupLabels': ['Conbercept eye drop (0.1mg/ mL)', 'Conbercept eye drop (0.5mg/ mL)', 'Conbercept eye drop (1.0mg/ mL)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'In the second stage, subjects will be receive Conbercept eys drop or a placebo.', 'armGroupLabels': ['Conbercept eye drop (0.5mg/ mL)', 'Conbercept eye drop (1.0mg/ mL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deng yingping', 'role': 'CONTACT', 'email': 'Dyp588@163.com'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Deng Yingping', 'role': 'CONTACT', 'email': 'Dyp558@163.com', 'phone': '18980601736'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kanghong Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}