Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01360151
Status:
UNKNOWN
Last Update Posted:
2011-05-30
First Post:
2011-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077362', 'term': 'Verteporfin'}], 'ancestors': [{'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-27', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in cytokine levels at 1 week, 1 month and 3 month', 'timeFrame': 'baseline, 1 week, 1 month, 3 month', 'description': '1. To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group\n2. To compare the change of cytokine level of aqueous humor after combination treatment of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy.(1 week, 1 month, 3 month)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['VEGF (Vascular endothelial growth factor)'], 'conditions': ['Polypoidal Choroidal Vasculopathy']}, 'descriptionModule': {'briefSummary': 'This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.', 'detailedDescription': 'To compare the effect of combination therapy of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of Lucentis™ on this increased vascular endothelial growth factor level. Additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '\\<Polypoidal choroidal vasculopathy group\\>\n\nInclusion Criteria:\n\n* Male or Female patients ≥ 45yrs of age\n* Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters\n* Signed written informed consent\n* Evidence of Polypoidal choroidal vasculopathy , active in disease activity.\n* Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography\n* Confirmed to be active in disease activity by fluorescein angiography\n* The total lesion must have the greatest linear dimension less than 5400 microns ( \\~9 MPS Disc Areas ) as delineated by indocyanine green angiography\n* Had not been treated in the past\n* Patients willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n* Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye\n* Have known hypersensitivity to Visudyne® and Lucentis™\n* Previous treatment with external-beam radiation therapy or transpupillary thermotherapy\n* History of vitrectomy\n* Intraocular surgery,yttrium aluminum garnet(YAG) laser\\< 1month before day 0\n* Additional eye disease that could compromise visual acuity\n* Ocular inflammation\n* Vitreous hemorrhage\n* Uncontrolled glaucoma\n* Current use or of likely need for systemic medications known to be toxic to the eye.\n* Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access\n* Are participating in another clinical study.\n* Disciform scar\n* Mental illness that precludes the patient from giving informed consent\n* Patients who are considered potentially unreliable\n\n\\<Control group\\>\n\n-Age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT01360151', 'briefTitle': 'Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'orgStudyIdInfo': {'id': '1-Lee'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection', 'interventionNames': ['Drug: ranibizumab(Lucentis), verteporfin(Visudyne)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active comparator', 'description': 'Arm 2 : Treatment of verteporfin(Visudyne)', 'interventionNames': ['Drug: ranibizumab(Lucentis), verteporfin(Visudyne)']}, {'type': 'NO_INTERVENTION', 'label': 'normal control group', 'description': 'Arm 3 : normal control group', 'interventionNames': ['Drug: ranibizumab(Lucentis), verteporfin(Visudyne)']}], 'interventions': [{'name': 'ranibizumab(Lucentis), verteporfin(Visudyne)', 'type': 'DRUG', 'otherNames': ['ranibizumab(Lucentis) : 0.5mg/0.05ml', 'verteportin (Visudyne) : 15mg (6mg/m2)'], 'description': 'ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection', 'armGroupLabels': ['active comparator', 'experimental', 'normal control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Ki Lee, MD, PhD', 'role': 'CONTACT', 'email': 'wklee@catholic.ac.kr', 'phone': '82-2-10-3265-1262'}, {'name': 'Mee Yon Lee, MD', 'role': 'CONTACT', 'email': 'deenie@daum.net', 'phone': '82-10-3230-1863'}], 'facility': 'Won Ki Lee', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ophthalmology', 'oldOrganization': "Professor, Seoul St. Mary's Hospital, Catholic University of Korea, School of Medicine"}}}}