Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT01370135
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2011-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of degree of iris rubeosis', 'timeFrame': '12 Months', 'description': 'Main outcome measure is the change of degree of iris rubeosis as documented by iris fluorescein angiography as measured 12 months after the first ranibizumab injection.'}], 'secondaryOutcomes': [{'measure': 'changes in intraocular pressure', 'timeFrame': '12 Months', 'description': '• to document changes in intraocular pressure measurements with the Goldmann applanation tonometer'}, {'measure': 'changes in best corrected visual acuity (BCVA)', 'timeFrame': '12 Months', 'description': '• to document changes in best corrected visual acuity (BCVA) measured on 4 meters'}, {'measure': 'numbers of additional interventions', 'timeFrame': '12 Months', 'description': '• to document numbers of additional interventions or anti-glaucomatous medications 12 months after injection'}, {'measure': 'quality of life', 'timeFrame': '12 Months', 'description': '• to document changes of quality of life'}, {'measure': 'Number of adverse events in all participants', 'timeFrame': '12 Months', 'description': '• to evaluate the safety of intravitreal injections of ranibizumab (0.5 mg) as adjunctive in patients with rubeosis and neovascular glaucoma using the number of adverse events.'}, {'measure': 'changes in gonioscopy', 'timeFrame': '12 Months', 'description': '• to document changes in gonioscopy of the anterior chamber angle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neovascular glaucoma', 'rubeosis', 'anterior chamber', 'intraocular', 'intravitreal injections', 'Lucentis', 'Ranibizumab', 'short ans longterm effects', 'best corrected visual acuity', 'gonioscopy', 'BCVA', 'quality of life'], 'conditions': ['Neovascular Glaucoma', 'Rubeosis']}, 'referencesModule': {'references': [{'pmid': '23893090', 'type': 'DERIVED', 'citation': 'Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.'}], 'seeAlsoLinks': [{'url': 'http://www.uksh.de/Augenklinik_Luebeck/index.html', 'label': 'University of Lübeck - Department of Ophthalmology - Germany'}]}, 'descriptionModule': {'briefSummary': 'Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris surface induced by an increased level of vascular endothelial growth factor (VEGF). In progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is often difficult to control and frequently results in loss of vision.\n\nThe aim of this study is to analyze the short- and long-term outcome after adjuvant intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to analyze the role of ranibizumab within a holistic treatment regime.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. neo-vascular glaucoma or rubeosis\n\n * definition of neo-vascular glaucoma: patient with iris neovascularization with intraocular pressure elevation (exceeding 21 mmHg)\n * definition of rubeosis: patient with iris neovascularization without intraocular pressure elevation (≤21 mmHg)\n2. an available follow-up of 12 months\n3. written informed consent\n4. visual acuity of light perception or better.\n\nExclusion Criteria:\n\n1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)\n2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months\n3. ventricular tachyarrhythmias requiring ongoing treatment\n4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation\n5. Clinically significant impaired renal or hepatic function\n6. Stroke within 12 month before trial entry.\n7. Known serious allergies to the fluorescein dye use in angiography\n8. Known contraindications to the components of Lucentis® formulation.\n\nOcular concomitant conditions/ diseases\n\n1. Active intraocular inflammation (grade trace or above) in either eye\n2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye\n3. History of uveitis in either eye\n4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion\n5. Angle block glaucoma\n6. Phthisis\n7. Intraocular Pressure \\<10mmHg\n\nCompliance/ Administrative\n\n1. Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion\n2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.\n3. Pregnant or nursing (lactating) women\n4. Inability to comply with study or follow-up procedures.\n5. Any treatment with an investigational agent in the past 60 days for any condition.'}, 'identificationModule': {'nctId': 'NCT01370135', 'acronym': 'LucNVG0108', 'briefTitle': 'Study to Evaluate the Effects of Ranibizumab (Lucentis) for Patients With Rubeosis and Neovascular Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'An Open Label, Prospective, Monocenter, Prove of Concept Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections as Adjuvant for Patients With Rubeosis and Neovascular Glaucoma', 'orgStudyIdInfo': {'id': 'LucNVG0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucentis (Ranibizumab)', 'interventionNames': ['Drug: 0.5mg intraocular Ranibizumab (Lucentis)']}], 'interventions': [{'name': '0.5mg intraocular Ranibizumab (Lucentis)', 'type': 'DRUG', 'description': 'short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma', 'armGroupLabels': ['Lucentis (Ranibizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Lübeck - Department of Ophthalmology', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Salvatore Grisanti, M.D. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lübeck - Department of Ophthalmology: Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Julia Lüke', 'investigatorFullName': 'Dr. Julia Lueke', 'investigatorAffiliation': 'University of Luebeck'}}}}