Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT00140803
Status:
COMPLETED
Last Update Posted:
2007-07-12
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077362', 'term': 'Verteporfin'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], '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'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-11', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to determine the effect of Visudyne therapy in combination with 4 mg intravitreal triamcinolone on the mean change in BCVA at Month 12.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': '• Proportion of patients having a 15 letter (3 lines) loss or more in BCVA', 'timeFrame': '12 months'}, {'measure': '• Proportion of patients having a 15 letter (3 lines) improvement or more in BCVA', 'timeFrame': '12 months'}, {'measure': '• Proportion of patients requiring re-treatment at any time during the study', 'timeFrame': '12 months'}, {'measure': '• The number of re-treatments required', 'timeFrame': '12 months'}, {'measure': '• Difference in treatment effect between 1 mg and 4 mg of triamcinolone acetonide', 'timeFrame': '12 months'}, {'measure': '• The change in MNREAD score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.', 'detailedDescription': 'This is a randomized, single-masked (VA examiners, angiographic graders), multi-center, Phase 2 study with 3 arms comparing VISUDYNE therapy in combination with intravitreal injection of either a 1 mg or 4 mg of triamcinolone with VISUDYNE therapy without intravitreal triamcinolone in a 1:1:1 ratio.\n\nRe-treatment may be administered at 3 month intervals (\uf0b1 14 days) if evidence of CNV leakage is detected by fluorescein angiography.\n\nAt baseline and at 3 month (+ 14 days) intervals patients will undergo the following assessments: ophthalmic examination, best corrected visual acuity, fluorescein angiography, and color fundus photography. The eligibility criteria for inclusion into the study and re-treatment of patients will be based on fluorescein angiography. Patients receiving treatment at day-1, week-3, and week-6 following the treatment will have best corrected ETDRS visual acuity testing and ophthalmic. Those patients not being re-treated will have will have best corrected ETDRS visual acuity testing and ophthalmic examination at week-6 following the re-treatment evaluation visit.\n\nAdverse events will be assessed throughout the study.\n\nExpected time for recruitment is 6 months; all patients will be followed for the period of 12 months in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 50 years or older\n\n * Subfoveal CNV secondary to age-related macular degeneration\n * Area of the CNV at least 50% of the area of the total neovascular lesion\n * The lesion is either minimally classic or occult with no classic\n * If the lesion is occult with no classic then subjects must have presumed recent disease progression in the study eye in the judgment of the Investigator and as defined by presence of blood associated with the lesion or vision loss or lesion growth reported or objectively recorded within the preceding 3 months before randomization to treatment\n * Baseline BCVA score between 73 and 19 letters on the ETDRS scale (approximately 20/40 to 20/400)\n * Lesion size \\< 5400 microns\n * Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects may not be randomized to treatment if they:\n\n 1. Have evidence of predominantly classic CNV, clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, axial myopia greater than -6 diopters, or other precursors of choroidal neovascularization\n 2. Have additional eye disease that compromises the visual acuity of the study eye.\n 3. Are receiving or require chronic concomitant therapy with systemic or topical ocular corticosteroids or NSAIDS. Chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study). A low dose (up to 100 mg po qd) of aspirin (ASA) taken for prophylaxis of MI and/or stroke is permitted during the study.\n 4. Are using coumadin.\n 5. Have known hypersensitivity to verteporfin or triamcinolone\n 6. Have CNV that does not involve the geometric center of the foveal avascular zone, as determined by color photography and fluorescein angiography\n 7. Are unable to be photographed to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access\n 8. Have lens opacities which, in the investigator\'s opinion, would progress during the course of the study and would affect central vision in the study eye. Such cataracts may be removed at least 2 months before entering the subject in the study\n 9. Have a history of treatment for CNV, other than confluent laser photocoagulation, in the study eye (e.g., PDT, submacular surgery, radiotherapy or macular scatter "grid" laser photocoagulation\n 10. Are participating in another clinical trial requiring follow-up examinations or are receiving or have received any experimental treatment for CNV or any other investigational new drug within 12 weeks prior to the start of study treatment\n 11. Have an intraocular pressure greater than 21 mm Hg on or off medication on entry to the study.\n 12. Have received prior treatment with another anti-angiogenic compound (e.g., Sandostatin®, LY333531, Macugen, RhuFab, etc.) within 6 months prior to screening\n 13. Are unwilling or unable to follow or comply with all study-related procedures.'}, 'identificationModule': {'nctId': 'NCT00140803', 'briefTitle': 'Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Eye, Ear & Throat Hospital'}, 'officialTitle': 'A Randomized, Single-Masked, Multi-Center, Phase 2 Evaluation Of The Effect Of PDT Using Visudyne In Combination With Intravitreal Injection Of Either 0 mg, 1mg or 4mg of Kenalog In Subfoveal Occult & Minimally Classic CNV Secondary To ARMD', 'orgStudyIdInfo': {'id': 'VISTA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Visudyne', 'type': 'DRUG'}, {'name': 'Kenalog', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Eye, Ear & Throat Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'V5Z 3N9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vh/UBC Eye Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Richard F. Spaide, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Eye, Ear & Throat Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Eye, Ear & Throat Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'QLT Inc.', 'class': 'INDUSTRY'}]}}}