OXEYE: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

Sponsor

Oxular Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05697809

Collaborator

(none)

128

Enrollment

Arms

23.6

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: OXU-001 Device: Semi-automated suprachoroidal illuminated microcatheter Drug: Ozurdex® Ophthalmic Intravitreal Implant	Phase 2

Detailed Description

Fifty-two (52) week phase 2 trial with two parts. Part A is an open-label, randomized, single-dose two treatment arm comparison of two dose levels of sustained-release suprachoroidal OXU-001 (DEXAspheres® administered using the Oxulumis® illuminated microcatheterization device) in subjects with Diabetic Macular Edema.

Part B is a randomized, masked, active comparator, single-dose, three treatment arm comparison of two dose levels of suprachoroidal OXU-001 and IVT Ozurdex® to evaluate the safety, tolerability, efficacy, and durability in subjects with Diabetic Macular Edema (DME).

In Part A, after a screening period, approximately 18 adult female or male subjects will be randomized in a 1:1 ratio to receive a single administration of one of two dose levels of OXU-001 (mid-dose or high-dose).

In Part B, after a screening period, approximately 110 adult female or male subjects will be randomized in a 2:2:1 ratio to receive a single administration of one of two dose levels of OXU-001 (Dose 1 or Dose 2) or Ozurdex®.

From Week 12, subjects will be assessed for the need for follow-on treatment. The follow-up period after treatment administration will be up to fifty-two (52) weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The trial will include previously IVT anti-VEGF treated (in Part A and B) and treatment-naive (in Part B only) DME subjects. In 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. In 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®The trial will include previously IVT anti-VEGF treated (in Part A and B) and treatment-naive (in Part B only) DME subjects. In 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. In 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®

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Part A is open-label, no masking. Part B is masked for the subject and the outcomes assessing site team and central reading center.

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1: OXU-001 / Mid dose The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.	Drug: OXU-001 Suprachoroidal sustained release dexamethasone acetate Other Names: DEXAspheres® Device: Semi-automated suprachoroidal illuminated microcatheter Ophthalmic administration device Other Names: Oxulumis®
Experimental: A2: OXU-001 / High Dose The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied.	Drug: OXU-001 Suprachoroidal sustained release dexamethasone acetate Other Names: DEXAspheres® Device: Semi-automated suprachoroidal illuminated microcatheter Ophthalmic administration device Other Names: Oxulumis®
Experimental: B1: OXU-001 / Mid Dose The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 1 (mid dose) will be applied.	Drug: OXU-001 Suprachoroidal sustained release dexamethasone acetate Other Names: DEXAspheres® Device: Semi-automated suprachoroidal illuminated microcatheter Ophthalmic administration device Other Names: Oxulumis®
Experimental: B2: OXU-001 / High Dose The Oxulumis® device will be used for the administration of OXU-001 (sustained release dexamethasone acetate) via suprachoroidal microcatheterization. A single treatment with dose level 2 (high dose) will be applied. This dose may be adpated based on the outcome of a Week 6 data review of Part A	Drug: OXU-001 Suprachoroidal sustained release dexamethasone acetate Other Names: DEXAspheres® Device: Semi-automated suprachoroidal illuminated microcatheter Ophthalmic administration device Other Names: Oxulumis®
Active Comparator: B3: Ozurdex® A single treatment with intravitreal Ozurdex®	Drug: Ozurdex® Ophthalmic Intravitreal Implant Ophthalmic dexamethasone intravitreal implant Other Names: intravitreal dexamethasone implant

Outcome Measures

Primary Outcome Measures

Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest [Week 24]
Treatment-emergent adverse events are defined as events emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Frequency and severity of treatment-emergent device adverse effects [Week 24]
Treatment-emergent device adverse effects are defined as effecs emerging following administration of study treatment at Visit 2 (Baseline, Day 0)

Other Outcome Measures

Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest [Week 52]
Treatment-emergent adverse events are defined as events emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Frequency and severity of treatment-emergent device adverse effects [Week 52]
Treatment-emergent device adverse effects are defined as effecs emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Mean Change in Best-Corrected Visual Acuity (BCVA) compared to baseline, Visit 2, Day 0 [Week 24]
Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology
Mean Change in Central Subfield Thickness (CST) compared to baseline, Visit 2, Day 0 [Week 24]
Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT)
Time interval to subjects requiring follow-on treatment (from baseline, Visit 2, Day 0) [From Week 12 through Week 52]
Timepoint for meeting pre-specified criteria of disease activity recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Treatment naïve group (Part B), any IVT anti-VEGF treatments in the study eye are exclusionary regardless of the time interval since injection.
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:
Subject has received less than 3 anti-VEGF injections since treatment initiation (at least three injections must have been received for eligibility).
Time interval between the first anti-VEGF injection and screening is more than 40 weeks.
Last injection with ranibizumab or bevacizumab within 4 weeks prior to screening.
Last injection with aflibercept within 8 weeks prior to screening.
Last injection with faricimab or brolucizumab within 12 weeks prior to screening.
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.