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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05697809
Other study ID # OXUCT-102 - OXEYE
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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