A Multi-Center, Randomized, Parallel-Group, Phase 2, Masked, Three-Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared With Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects With Diabetic Macular Edema (OXEYE)

OXUCT-102 - OXEYE

The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.

2023-08-07

2024-11-30

2025-03-01

Active (not recruiting)

Early phase I

3

Inclusion Criteria: * Type 1 or Type 2 diabetes mellitus * Diabetic Macular edema involving the center of the fovea in the study eye * Best corrected visual acuity in the study eye between 34 and 78 (early treatment of diabetic retinopathy study) ETDRS letters Exclusion Criteria: * Macular edema is considered due to a cause other than diabetes mellitus in the study eye * Condition, in the study eye, in which visual acuity is not expected to improve from the resolution of macular edema * Macular laser photocoagulation or panretinal laser photocoagulation in the study eye performed within 16 weeks prior to screening * Active proliferative diabetic retinopathy (PDR) or sequelae of PDR in the study eye * Prior treatment with anti-VEGF in the study eye: 1. Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection. 2. Previously treated group (Part A and B), subjects in the previously treated group are excluded if they meet any of the below criteria for the study eye at screening: 1. Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility). 2. Time interval between the first anti-VEGF injection and screening is more than 40 weeks. 3. Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening. 4. Last injection with aflibercept within 8 weeks prior to screening. 5. Last injection with faricimab or brolucizumab within 12 weeks prior to screening. 6. Prior treatment with SUSVIMO (Port Delivery System) implant is exclusionary. * Prior ocular treatment with steroid injections (periocular, subtenon, intravitreal) or intravitreal implants in the study eye. * Prior treatment with suprachoroidal steroids in the study eye is exclusionary. * Active malignancy or history of malignancy within the past 5 years * Uncontrolled diabetes with a hemoglobin A1c (HbA1c) more than 12% or any other uncontrolled systemic disease at screening.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The trial will include previously IVT anti-VEGF treated (in Part A and B) and treatment-naive (in Part B only) DME subjects.\n\nIn Part A, approximately 18 subjects will be randomly assigned (ratio 1:1) to receive either a mid-dose or high-dose of suprachoroidal OXU-001.\n\nIn Part B, approximately 110 subjects will be randomly assigned (ratio 2:2:1) to receive a single treatment of either suprachoroidal OXU-001 Dose 1, or Dose 2 or intravitreal Ozurdex®', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Part A is open-label, no masking. Part B is masked for the subject and the outcomes assessing site team and central reading center.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2024-02-13