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NCT05697809 | Active, not recruiting | Diabetic Macular Edema

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

Condition or disease

Diabetic Macular Edema

Intervention/treatment

READ-001

Semi-automated suprachoroidal illuminated microcatheter

Ozurdex® Ophthalmic Intravitreal Implant

Phase

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 Type : Interventional
Estimated Enrollment : 3 participants
Masking : Triple
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)
Actual Study Start Date : August 7, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : March 1, 2025
Arm Intervention/treatment

Experimental: A1: OKU-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.

Friend: OXU-001

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.

Device: Semi-automated suprachoroidal illuminated microcatheter

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.

Friend: OXU-001

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

Device: Semi-automated suprachoroidal illuminated microcatheter

Active Comparator: B3: Ozurdex®

A single treatment with intravitreal Ozurdex®

Friend: OXU-001
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Retinal Research Institute, LLC

Phoenix, Arizona, United States, 85053

Not yet recruiting

United States, Florida

Blue Ocean Clinical Research West

Clearwater, florida, United States, 33761

Not yet recruiting

United States, Illinois

University Retina and Macula Associates

Oak Forest, Illinois, United States, 60452

Not yet recruiting

United States, Minnesota

Retina Consultants of Minnesota

Minneapolis, Minnesota, United States, 55337

Not yet recruiting

United States, Nevada

Sierra Eye Associates

Reno, Nevada, United States, 89502

Not yet recruiting

United States, Texas

Retina Consultants of Texas

Houston, Texas, United States, 77380

Not yet recruiting

United States, Texas

Valley Retina Institute, PA

McAllen, Texas, United States, 78503

Not yet recruiting

United States, Texas

Retinal Consultants of Texas - San Antonio

Saint Anthony, Texas, United States, 78240

Not yet recruiting

Puerto Rico,

Emmanuelli Research and Development Center, LLC

Arecibo, Puerto Rico, 00612