Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT01269151
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2011-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD
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': '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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.', 'timeFrame': '12 months', 'description': 'Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.'}], 'secondaryOutcomes': [{'measure': 'to document changes in best corrected visual acuity (BCVA) measured on 4 meters,', 'timeFrame': '12 months', 'description': 'to document changes in best corrected visual acuity (BCVA) measured on 4 meters,'}, {'measure': 'to document changes in angiography', 'timeFrame': '12 months', 'description': 'to document changes in angiography'}, {'measure': 'to document changes in optical coherence tomography (OCT)', 'timeFrame': '12 months', 'description': 'to document changes in optical coherence tomography (OCT)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Age-Related Macular Degeneration', 'Retinal Function', 'multifocal-ERG', 'Electroretinography', 'microperimetry', 'Lucentis', 'Ranibizumab', 'longterm effects', 'best corrected visual acuity', 'BCVA'], 'conditions': ['Age-Related Macular Degeneration', 'Retinal Function']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uksh.de/Augenklinik_Luebeck/index.html', 'label': 'University of Luebeck - Department of Ophthalmology - Germany'}]}, 'descriptionModule': {'briefSummary': 'Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function. No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis. The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease. The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients above 50 years of age\n2. wet age-related macular degeneration (AMD)\n3. an available follow-up of 12 months\n4. written informed consent\n5. visual acuity of 0.1 or better\n\nExclusion Criteria:\n\nSystemic conditions or treatments\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 within the last 6 months\n3. ventricular tachyarrythmias 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, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion\n5. Angle block glaucoma\n6. Phthisis\n7. Intraocular Pressure \\<10mmHg\n8. Macular or retinal dystrophies\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. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.\n3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.\n4. Pregnant or nursing (lactating) women\n5. Inability to comply with study or follow-up procedures.\n6. Any treatment with an investigational agent in the past 3 months any condition.'}, 'identificationModule': {'nctId': 'NCT01269151', 'acronym': 'LucERG', 'briefTitle': 'Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'A Prospective, Non-randomized, Mono-center, Cohort Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections on Retinal Function in Patients With Wet Age-related Macular Degeneration During Twelve Month', 'orgStudyIdInfo': {'id': 'LucERG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucentis (Ranibizumab)', 'interventionNames': ['Drug: Lucentis (Ranibizumab)']}], 'interventions': [{'name': 'Lucentis (Ranibizumab)', 'type': 'DRUG', 'description': 'Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry', 'armGroupLabels': ['Lucentis (Ranibizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Luebeck - Department of Ophthalmology', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Salvatore Grisanti, M.D. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Luebeck - Department of Ophthalmology: Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Matthias Lüke', 'investigatorFullName': 'Dr. Matthias Lueke', 'investigatorAffiliation': 'University of Luebeck'}}}}