Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-28 @ 8:18 AM
Study NCT ID:
NCT02957760
Status:
UNKNOWN
Last Update Posted:
2016-11-28
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006918', 'term': 'Hydroxyurea'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retinal capillary non-perfusion', 'timeFrame': '3 months', 'description': 'To assess the percentage of subjects in whom one of the following events will not be observed at W13 (any event being considered as one of the criteria of worsening of retinal capillary non-perfusion):\n\n* Occurence of at least one direct sign of retinal ischemia: Increase of more than 30% of peripheral retinal non-perfusion on large-field angiography or of the central avascular zone of the retina,\n* Occurence of at least one indirect sign of retinal ischemia: reperfusion of the aterial iris circle, rubeosis iridis, neovascular glaucoma or abolition of the afferent pupillary reflex.'}], 'secondaryOutcomes': [{'measure': 'retinal capillary non-perfusion', 'timeFrame': '2 weeks, 2 months and 6 months', 'description': 'Same criteria of retinal non perfusion as for primary end point'}, {'measure': 'Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.', 'timeFrame': '2 weks, 2 months, 3 months and 6 months', 'description': 'HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Central Retinal Vein Occlusion, Non-Ischemic']}, 'descriptionModule': {'briefSummary': 'The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine', 'detailedDescription': 'introduction : The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine.\n\nHypothesis : Hydroxycarbamide (HC) by reducing the erythrocyte adhesion to the endothelium may prevent or delay the onset of retinal capillary non-perfusion in patients with CRVO.\n\nPrimary objective: To assess the efficacy at 3 months of treatment with HC on retinal capillary perfusion in patients with a recent CRVO.\n\nSecondary Objectives: To evaluate the safety of the treatment, the efficacy to 6 months on retinal perfusion of the treatment with HC (HC peak effect on the red cell adhesion in vitro), and the biological effects of HC, in particular on adhesion to endothelium and erythrocyte hemorheological parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes of at least 45 years of age.\n* with social protection\n* Presenting CRVO for less than 1 month duration\n* With a decrease of visual acuity and with the best corrected visual acuity lower than 6/10 (73 ETDRS letters)\n* Signature of informed consent\n\nExclusion Criteria:\n\n* predictable lack of compliance to the protocol\n* monophtalmic patient or any ocular history or condition that could interfere with the study course or results interpretation.\n* active systemic disease\n* sickle cell disease\n* myeloproliferative disease\n* myelosuppression\n* kidney or liver insufficiency\n* ongoing treatment with hydroxycarbamide or anticoagulant\n* Pregnancy, breast-feeding, no efficient contraception (for both sexes)\n* wish of paternity (for males of al least 45 years of age)'}, 'identificationModule': {'nctId': 'NCT02957760', 'acronym': 'PNPRO_HC', 'briefTitle': 'Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts"}, 'officialTitle': 'Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.', 'orgStudyIdInfo': {'id': 'P15-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hydroxycarbamid', 'type': 'DRUG', 'otherNames': ['siklos'], 'description': '20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent Vinet', 'role': 'CONTACT', 'email': 'lvinet@15-20.fr', 'phone': '+33140021126'}, {'name': 'Romain Duvernois', 'role': 'CONTACT', 'email': 'rduvernois@15-20.fr', 'phone': '+33140021124'}], 'facility': 'CHNO des Quinze-Vingts', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laurent Vinet', 'role': 'CONTACT', 'email': 'lvinet@15-20.com', 'phone': '+33140021126'}], 'overallOfficials': [{'name': 'Jean-François Girmens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHNO des Quinze-Vingts'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hopital Universitaire Robert-Debre', 'class': 'OTHER'}, {'name': 'Institut National de la Transfusion Sanguine', 'class': 'OTHER'}, {'name': 'Keyrus Biopharma', 'class': 'OTHER'}, {'name': 'For Drug Consulting', 'class': 'OTHER'}, {'name': 'Theravia', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}