Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT05919693
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2023-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant Care Provider Outcomes Assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1 is a multiple-dose escalation study and patients will be enrolled sequentially in ascending order through the dose levels until the highest level is reached or until a maximum tolerated dose is reached, whichever comes first.\n\nPart 2 is randomized single-masked study where patients on all arms will be enrolled in parallel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2024-08-26', 'completionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'dispFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '3 months', 'description': 'Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Best-corrected Visual Acuity', 'timeFrame': '3 months', 'description': 'Best-corrected Visual Acuity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neovascular Age-related Macular Degeneration (NVAMD)', 'Diabetic Macular Edema (DME)', 'Age-related Macular Degeneration (AMD)'], 'conditions': ['Neovascular Age-related Macular Degeneration (NVAMD)', 'Diabetic Macular Edema (DME)']}, 'descriptionModule': {'briefSummary': 'EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.\n\nIn the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.\n\nIn the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.', 'detailedDescription': 'EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.\n\nIn the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.\n\nIn the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity\n* DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age\n* Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.\n* DME patients must have vision loss in the study eye\n* NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye\n\nExclusion Criteria:\n\n* Be pregnant or breastfeeding\n* History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening\n* Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening\n* Any other condition except for DME or NVAMD or that could affect interpretation of study assessments'}, 'identificationModule': {'nctId': 'NCT05919693', 'acronym': 'AMARONE', 'briefTitle': 'A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeBiotech Ltd.'}, 'officialTitle': 'A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)', 'orgStudyIdInfo': {'id': 'EYE103-101'}, 'secondaryIdInfos': [{'id': 'MK-3000-003', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'Part 1 MAD Portion Dose 1 - Low Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'Part 1 MAD Portion Dose 2 - Low-Mid Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': 'Part 1 MAD Portion Dose 3 - Mid-High Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4', 'description': 'Part 1 MAD Portion Dose 4 - High Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'DME Medium Dose', 'description': 'Part 2 Naïve DME monotherapy Medium Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'DME High Dose', 'description': 'Part 2 Naïve DME monotherapy High Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Naïve NVAMD Medium Dose', 'description': 'Part 2 Naïve NVAMD combination therapy Medium Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Naïve NVAMD High Dose', 'description': 'Part 2 Naïve NVAMD combination therapy High Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Experienced NVAMD Medium Dose', 'description': 'Part 2 Experienced NVAMD combination therapy Medium Dose', 'interventionNames': ['Drug: EYE103']}, {'type': 'EXPERIMENTAL', 'label': 'Experienced NVAMD High Dose', 'description': 'Part 2 Experienced NVAMD combination therapy High Dose', 'interventionNames': ['Drug: EYE103']}], 'interventions': [{'name': 'EYE103', 'type': 'DRUG', 'description': 'EYE103 is a humanized antibody formulated for IVT administration', 'armGroupLabels': ['DME High Dose', 'DME Medium Dose', 'Dose 1', 'Dose 2', 'Dose 3', 'Dose 4', 'Experienced NVAMD High Dose', 'Experienced NVAMD Medium Dose', 'Naïve NVAMD High Dose', 'Naïve NVAMD Medium Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix, AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Bakersfield, CA', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Modesto, CA', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Mountain View, CA', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento, CA', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95841', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento, CA', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs, Colorado', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80288', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lakewood, CO', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pompano Beach', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'Lemont, NV', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Hagerstown, MD', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Reno, NV', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'West Columbia, SC', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Germantown, TN', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Knoxville, TN', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville, TN', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Abilene, TX', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '79109', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Amarillo, TX', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin, TX', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Bellaire, TX', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Katy, TX', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'McAllen, TX', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Plano, TX', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Round Rock, TX', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio, TX', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'The Woodlands, TX', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': 'C1121ABB', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Ciudad Autonoma Buenos Aires'}, {'zip': '1023', 'city': 'Caba', 'country': 'Argentina', 'facility': 'Caba, Argentina'}, {'zip': '00612', 'city': 'Arecibo', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Arecibo, PR', 'geoPoint': {'lat': 18.47245, 'lon': -66.71573}}, {'zip': 'NW10 7NS', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'London, England', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G7LB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'London, UK', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeBiotech Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}