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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2024-12-05

Brief Summary

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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.

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Detailed Description

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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 A was only partially recruited due a non-safety related sponsor decision to stop further recruitment after 3 randomized and treated subjects.

\--- 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).

\--- Part B was not initiated due a non-safety related sponsor decision in Dec 2023.

\--- 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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial was designed to 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® Note: Due to a non-safety related sponsor decision in Dec 2024 trial recruitment was stopped after only 3 subjects randomized and treated in Part A of the clinical trial. Part B was therefore not initiated.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

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OXU-001

Suprachoroidal sustained release dexamethasone acetate

Intervention Type DRUG

Semi-automated suprachoroidal illuminated microcatheter

Ophthalmic administration device

Intervention Type DEVICE

Ozurdex® Ophthalmic Intravitreal Implant

Ophthalmic dexamethasone intravitreal implant

Intervention Type DRUG

Other Intervention Names

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DEXAspheres® Oxulumis® intravitreal dexamethasone implant

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No