Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:03 PM
Study NCT ID:
NCT00373659
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2006-09-07', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual acuity vs baseline'}, {'measure': 'Change in OCT central retinal thickness vs baseline'}], 'secondaryOutcomes': [{'measure': 'Number of injections over 1 year'}, {'measure': 'Number of consecutive monthly injections until fluid-free'}, {'measure': 'Injection free interval'}, {'measure': 'Correlations of injection frequency with baseline lesion characteristics and visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neovascularization', 'Age-related macular degeneration', 'Ranibizumab (Lucentis)', 'Optical coherence tomography', 'Intravitreal injection'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.', 'detailedDescription': 'In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50 years or older\n* Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression\n* OCT central retinal thickness ≥ 300 microns\n* Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye\n\nExclusion Criteria:\n\n* More than 3 prior treatments with verteporfin photodynamic therapy\n* Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)\n* Previous subfoveal focal laser photocoagulation in the study eye\n* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0\n* Subfoveal fibrosis or atrophy in the study eye\n* History of vitrectomy surgery in the study eye\n* Aphakia or absence of the posterior capsule in the study eye\n* History of idiopathic or autoimmune-associated uveitis in either eye'}, 'identificationModule': {'nctId': 'NCT00373659', 'briefTitle': 'An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study', 'orgStudyIdInfo': {'id': 'IST-FVF3102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ranibizumab (Lucentis)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Instiyute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Philip J Rosenfeld, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Philip J. Rosenfeld, MD, PhD', 'investigatorAffiliation': 'University of Miami'}}}}