Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06046118
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photobiomodulation in Dry Age Related Macular Degeneration
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity variation', 'timeFrame': '1 month, 2 months and 4 months after each cycle', 'description': 'ETDRS letters'}, {'measure': 'Drusen Volume Variation', 'timeFrame': '1 month, 2 months and 4 months after each cycle', 'description': 'Based on SD-OCT Heidelberg'}, {'measure': 'Contrast sensitivity variation', 'timeFrame': '1 month, 2 months and 4 months after each cycle', 'description': 'Based on Pelli Robson chart'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age related Macular Degeneration', 'Photobiomodulation'], 'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '39271642', 'type': 'DERIVED', 'citation': 'Borrelli E, Coco G, Pellegrini M, Mura M, Ciarmatori N, Scorcia V, Carnevali A, Lucisano A, Borselli M, Rossi C, Reibaldi M, Ricardi F, Vagge A, Nicolo M, Forte P, Cartabellotta A, Hasanreisoglu M, Kesim C, Demirel S, Yanik O, Bernabei F, Rothschild PR, Farrant S, Giannaccare G. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Nov;13(11):2855-2868. doi: 10.1007/s40123-024-01030-w. Epub 2024 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:\n\n* Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD?\n* Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group.\n\nTreatment consists in two cycles with two phases each:\n\n* 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened;\n* 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened.\n\nCycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).\n\nResearchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BCVA ETDRS \\> 40 L ETDRS at 4 meters\n* Diagnosis of DRY AMD AREDS grade 2-3\n* Ability to communicate well with the investigator and able to understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n* Concomitant epilepsy\n* Neurological diseases\n* Psychiatric pathologies\n* Herpes virus infections\n* Dense cataract\n* Pregnancy\n* Other significant ocular and/or retinal diseases'}, 'identificationModule': {'nctId': 'NCT06046118', 'acronym': 'DRUSEN', 'briefTitle': 'Photobiomodulation in Dry Age Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro'}, 'officialTitle': 'Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study', 'orgStudyIdInfo': {'id': 'PBM AMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light.\n\nCycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).', 'interventionNames': ['Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not.\n\nCycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).', 'interventionNames': ['Device: Sham Mask']}], 'interventions': [{'name': 'Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)', 'type': 'DEVICE', 'description': 'Each session consists of:\n\n* 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened)\n* 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened).\n\nCycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).', 'armGroupLabels': ['Treatment group']}, {'name': 'Sham Mask', 'type': 'DEVICE', 'description': 'Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Raphael Rothschild', 'role': 'CONTACT'}, {'name': 'Federico Bernabei', 'role': 'CONTACT', 'email': 'federico.bernabei89@gmail.com'}], 'facility': 'University of Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Busin', 'role': 'CONTACT'}, {'name': 'Marco Pellegrini', 'role': 'CONTACT', 'email': 'marco.pellegrini@hotmail.it'}], 'facility': 'Università degli Studi di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Iovino', 'role': 'CONTACT', 'email': 'claudioiovino88@gmail.com'}, {'name': 'Francesca Simonelli', 'role': 'CONTACT'}], 'facility': 'Università degli studi della Campania Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Reibaldi', 'role': 'CONTACT'}, {'name': 'Enrico Borrelli', 'role': 'CONTACT', 'email': 'borrelli.enrico@yahoo.com'}], 'facility': 'Università di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sibel Demirel', 'role': 'CONTACT', 'email': 'drsibeldemireltr@yahoo.com.tr'}], 'facility': 'University of Ankara', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Koç', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Murat Murat Hasanreisoğlu', 'role': 'CONTACT', 'email': 'drhasanreisoglu@gmail.com'}], 'facility': 'Koç University Hospital', 'geoPoint': {'lat': 38.73333, 'lon': 40.91667}}, {'city': 'Taunton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sarah Farrant', 'role': 'CONTACT', 'email': 'sarahfarrant@gmail.com'}], 'facility': 'Earlam and Christopher', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}], 'centralContacts': [{'name': 'Giuseppe Giannaccare', 'role': 'CONTACT', 'email': 'giuseppe.giannaccare@unicz.it', 'phone': '003909613647135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giuseppe Giannaccare', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro'}}}}