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

Phase 2

Active, not recruiting

Conditions: Diabetic Macular Edema

Interventions: Drug: Ozurdex® Ophthalmic Intravitreal Implant
Drug: OXU-001
Device: Semi-automated suprachoroidal illuminated microcatheter

Registration Number: NCT05697809

Lead Sponsor: Oxular Limited

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 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.

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B3: Ozurdex®	Ozurdex® Ophthalmic Intravitreal Implant	A single treatment with intravitreal Ozurdex®
A1: OXU-001 / Mid dose	Semi-automated suprachoroidal illuminated microcatheter	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.
B1: OXU-001 / Mid Dose	OXU-001	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.
B1: OXU-001 / Mid Dose	Semi-automated suprachoroidal illuminated microcatheter	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.
B2: OXU-001 / High Dose	OXU-001	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
B2: OXU-001 / High Dose	Semi-automated suprachoroidal illuminated microcatheter	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
A1: OXU-001 / Mid dose	OXU-001	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.
A2: OXU-001 / High Dose	OXU-001	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.
A2: OXU-001 / High Dose	Semi-automated suprachoroidal illuminated microcatheter	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.

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (9): Emmanuelli Research and Development Center, LLC
🇵🇷
Arecibo, Puerto Rico
Retinal Research Institute, LLC
🇺🇸
Phoenix, Arizona, United States
Blue Ocean Clinical Research West
🇺🇸
Clearwater, Florida, United States
Retina Consultants of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Sierra Eye Associates
🇺🇸
Reno, Nevada, United States
Retina Consultants of Texas
🇺🇸
Houston, Texas, United States
Retinal Consultants of Texas - San Antonio
🇺🇸
San Antonio, Texas, United States
University Retina and Macula Associates
🇺🇸
Oak Forest, Illinois, United States
Valley Retina Institute, PA
🇺🇸
McAllen, Texas, United States

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

Recruitment & Eligibility

Study & Design

Trial Locations

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