Clinical trial NCT05697809: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: Oxular Limited
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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®
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest
timeFrame: Week 24
measure: Frequency and severity of treatment-emergent device adverse effects
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
measure: Frequency and severity of ocular and systemic treatment emergent adverse events, serious adverse events, and adverse events of special interest
timeFrame: Week 52
measure: Frequency and severity of treatment-emergent device adverse effects
timeFrame: Week 52
measure: Mean Change in Best-Corrected Visual Acuity (BCVA) compared to baseline, Visit 2, Day 0
timeFrame: Week 24
measure: Mean Change in Central Subfield Thickness (CST) compared to baseline, Visit 2, Day 0
timeFrame: Week 24
measure: Time interval to subjects requiring follow-on treatment (from baseline, Visit 2, Day 0)
timeFrame: From Week 12 through Week 52
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research West
state: Florida
city: Oak Forest
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Minneapolis
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Houston
country: United States
facility: Retina Consultants of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas - San Antonio
state: Texas
city: Arecibo
country: Puerto Rico
facility: Emmanuelli Research and Development Center, LLC
Study officials:
affiliation: Oxular Limited
name: Friedrich Asmus, MD
role: STUDY_DIRECTOR
References: