Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00763802
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2008-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2008-09-30', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSME needing Photocoagulation', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Vision Loss', 'timeFrame': '24 months'}]}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '15708833', 'type': 'BACKGROUND', 'citation': 'Cunha-Vaz J, Bernardes R. Nonproliferative retinopathy in diabetes type 2. Initial stages and characterization of phenotypes. Prog Retin Eye Res. 2005 May;24(3):355-77. doi: 10.1016/j.preteyeres.2004.07.004. Epub 2004 Dec 16.'}, {'pmid': '14769598', 'type': 'BACKGROUND', 'citation': 'Lobo CL, Bernardes RC, Figueira JP, de Abreu JR, Cunha-Vaz JG. Three-year follow-up study of blood-retinal barrier and retinal thickness alterations in patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy. Arch Ophthalmol. 2004 Feb;122(2):211-7. doi: 10.1001/archopht.122.2.211.'}, {'pmid': '12504747', 'type': 'BACKGROUND', 'citation': 'Hayreh SS. Diabetic papillopathy and nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2002 Nov-Dec;47(6):600-2; author reply 602. doi: 10.1016/s0039-6257(02)00358-2. No abstract available.'}, {'pmid': '12365908', 'type': 'BACKGROUND', 'citation': 'Pires I, Bernardes RC, Lobo CL, Soares MA, Cunha-Vaz JG. Retinal thickness in eyes with mild nonproliferative retinopathy in patients with type 2 diabetes mellitus: comparison of measurements obtained by retinal thickness analysis and optical coherence tomography. Arch Ophthalmol. 2002 Oct;120(10):1301-6. doi: 10.1001/archopht.120.10.1301.'}, {'pmid': '28785768', 'type': 'DERIVED', 'citation': "Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780."}, {'pmid': '24680929', 'type': 'DERIVED', 'citation': 'Cunha-Vaz J, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.'}, {'pmid': '24080704', 'type': 'DERIVED', 'citation': 'Pires I, Santos AR, Nunes S, Lobo C, Cunha-Vaz J. Subclinical macular edema as a predictor of progression to clinically significant macular edema in type 2 diabetes. Ophthalmologica. 2013;230(4):201-6. doi: 10.1159/000354550. Epub 2013 Sep 25.'}, {'pmid': '23745006', 'type': 'DERIVED', 'citation': 'Nunes S, Ribeiro L, Lobo C, Cunha-Vaz J. Three different phenotypes of mild nonproliferative diabetic retinopathy with different risks for development of clinically significant macular edema. Invest Ophthalmol Vis Sci. 2013 Jul 10;54(7):4595-604. doi: 10.1167/iovs.13-11895.'}, {'pmid': '23614970', 'type': 'DERIVED', 'citation': 'Pires I, Santos AR, Nunes S, Lobo C. Macular thickness measured by stratus optical coherence tomography in patients with diabetes type 2 and mild nonproliferative retinopathy without clinical evidence of macular edema. Ophthalmologica. 2013;229(4):181-6. doi: 10.1159/000350593. Epub 2013 Apr 24.'}, {'pmid': '23204247', 'type': 'DERIVED', 'citation': 'Ribeiro ML, Nunes SG, Cunha-Vaz JG. Microaneurysm turnover at the macula predicts risk of development of clinically significant macular edema in persons with mild nonproliferative diabetic retinopathy. Diabetes Care. 2013 May;36(5):1254-9. doi: 10.2337/dc12-1491. Epub 2012 Nov 30.'}], 'seeAlsoLinks': [{'url': 'http://www.aibili.pt', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 diabetic patients with Mild non-prolipherative retinopathy fulfilling the inclusion criterion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes type 2 according to 1985 WHO criteria.\n* Age between 35 and 75 years.\n* Mild non-prolipherative retinopathy (based on ETDRS criteria)\n* Best Corrected Visual acuity \\>20 /25\n* Refraction with a spherical equivalent less than 5 Dp.\n* Inform consent\n\nExclusion Criteria:\n\n* Cataract or other eye disease that may interfere with fundus examinations\n* Glaucoma\n* Vitreous syneresis or posterior vitreous detachment\n* Other retinal vascular disease\n* Recent intraocular surgery\n* Previous laser therapy\n* Dilatation of the pupil \\< 5 mm'}, 'identificationModule': {'nctId': 'NCT00763802', 'acronym': 'CPM', 'briefTitle': 'Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2', 'organization': {'class': 'OTHER', 'fullName': 'Association for Innovation and Biomedical Research on Light and Image'}, 'officialTitle': 'Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2', 'orgStudyIdInfo': {'id': 'PTDC/SAU-OSM/72635/2006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MNPDR', 'description': 'Type 2 diabetic patients with Mild non-prolipherative retinopathy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000-548', 'city': 'Coimbra', 'state': 'Coimbra District', 'country': 'Portugal', 'facility': 'AIBILI', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}], 'overallOfficials': [{'name': 'José G Cunha-Vaz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Association for Innovation and Biomedical Research on Light and Image'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association for Innovation and Biomedical Research on Light and Image', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação para a Ciência e a Tecnologia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}