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

Primary Purpose

Diabetic Macular Edema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OXU-001
Semi-automated suprachoroidal illuminated microcatheter
Ozurdex® Ophthalmic Intravitreal Implant
Sponsored by
Oxular Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Immunosuppressive Agents, Immunologic Factors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Dexamethasone, Suprachoroidal Microcatheterization, Illuminated Microcatheterization, Sustained-Release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Retinal Research Institute, LLCRecruiting
  • Blue Ocean Clinical Research WestRecruiting
  • University Retina and Macula AssociatesRecruiting
  • Retina Consultants of MinnesotaRecruiting
  • Sierra Eye AssociatesRecruiting
  • Retina Consultants of TexasRecruiting
  • Valley Retina Institute, PARecruiting
  • Retinal Consultants of Texas - San AntonioRecruiting
  • Emmanuelli Research and Development Center, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

A1: OXU-001 / Mid dose

A2: OXU-001 / High Dose

B1: OXU-001 / Mid Dose

B2: OXU-001 / High Dose

B3: Ozurdex®

Arm Description

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.

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.

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.

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

A single treatment with intravitreal Ozurdex®

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2023
Last Updated
September 28, 2023
Sponsor
Oxular Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05697809
Brief Title
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
Acronym
OXEYE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxular Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Macular Edema, Edema, Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Immunosuppressive Agents, Immunologic Factors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Dexamethasone, Suprachoroidal Microcatheterization, Illuminated Microcatheterization, Sustained-Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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®
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1: OXU-001 / Mid dose
Arm Type
Experimental
Arm Description
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.
Arm Title
A2: OXU-001 / High Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
B1: OXU-001 / Mid Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
B2: OXU-001 / High Dose
Arm Type
Experimental
Arm Description
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
Arm Title
B3: Ozurdex®
Arm Type
Active Comparator
Arm Description
A single treatment with intravitreal Ozurdex®
Intervention Type
Drug
Intervention Name(s)
OXU-001
Other Intervention Name(s)
DEXAspheres®
Intervention Description
Suprachoroidal sustained release dexamethasone acetate
Intervention Type
Device
Intervention Name(s)
Semi-automated suprachoroidal illuminated microcatheter
Other Intervention Name(s)
Oxulumis®
Intervention Description
Ophthalmic administration device
Intervention Type
Drug
Intervention Name(s)
Ozurdex® Ophthalmic Intravitreal Implant
Other Intervention Name(s)
intravitreal dexamethasone implant
Intervention Description
Ophthalmic dexamethasone intravitreal implant
Primary Outcome Measure Information:
Title
Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest
Description
Treatment-emergent adverse events are defined as events emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Time Frame
Week 24
Title
Frequency and severity of treatment-emergent device adverse effects
Description
Treatment-emergent device adverse effects are defined as effecs emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest
Description
Treatment-emergent adverse events are defined as events emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Time Frame
Week 52
Title
Frequency and severity of treatment-emergent device adverse effects
Description
Treatment-emergent device adverse effects are defined as effecs emerging following administration of study treatment at Visit 2 (Baseline, Day 0)
Time Frame
Week 52
Title
Mean Change in Best-Corrected Visual Acuity (BCVA) compared to baseline, Visit 2, Day 0
Description
Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology
Time Frame
Week 24
Title
Mean Change in Central Subfield Thickness (CST) compared to baseline, Visit 2, Day 0
Description
Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT)
Time Frame
Week 24
Title
Time interval to subjects requiring follow-on treatment (from baseline, Visit 2, Day 0)
Description
Timepoint for meeting pre-specified criteria of disease activity recurrence
Time Frame
From Week 12 through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Friedrich Asmus, MD
Phone
+44 (0)1865 636200
Email
clinicaltrials@oxular.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Sea
Phone
+1 (484) 502-9814
Email
clinicaltrials@oxular.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Asmus, MD
Organizational Affiliation
Oxular Limited
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Ocean Clinical Research West
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Wykoff
First Name & Middle Initial & Last Name & Degree
Charles Wykoff, M.D., PhD
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants of Texas - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Emmanuelli Research and Development Center, LLC
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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