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

Diabetic Macular Edema Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05697809
• Other study ID #: OXUCT-102 - OXEYE
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 7, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Oxular Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: March 1, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• OXU-001
Suprachoroidal sustained release dexamethasone acetate

Device:
• Semi-automated suprachoroidal illuminated microcatheter
Ophthalmic administration device

Drug:
• Ozurdex® Ophthalmic Intravitreal Implant
Ophthalmic dexamethasone intravitreal implant

Locations

Country	Name	City	State
Puerto Rico	Emmanuelli Research and Development Center, LLC	Arecibo
United States	Blue Ocean Clinical Research West	Clearwater	Florida
United States	Retina Consultants of Texas	Houston	Texas
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Retina Consultants of Minnesota	Minneapolis	Minnesota
United States	University Retina and Macula Associates	Oak Forest	Illinois
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Retinal Consultants of Texas - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Oxular Limited

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Week 52
Other	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)	Week 52
Other	Mean Change in Best-Corrected Visual Acuity (BCVA) compared to baseline, Visit 2, Day 0	Assessed using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology	Week 24
Other	Mean Change in Central Subfield Thickness (CST) compared to baseline, Visit 2, Day 0	Assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT)	Week 24
Other	Time interval to subjects requiring follow-on treatment (from baseline, Visit 2, Day 0)	Timepoint for meeting pre-specified criteria of disease activity recurrence	From Week 12 through Week 52
Primary	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)	Week 24
Primary	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)	Week 24