Status:
COMPLETED
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Lead Sponsor:
Oxurion
Conditions:
Diabetes Mellitus
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3...
Eligibility Criteria
Inclusion
- Key
- Written informed consent obtained from the subject prior to screening procedures
- Male or female aged 18 years or older at the time of signing the informed consent
- Type 1 or type 2 diabetes
- BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
- Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
- Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
- BCVA ETDRS letter score ≥ 34 in the fellow eye
- Key
Exclusion
- Macular edema due to causes other than DME in the study eye
- Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
- Previous confounding medications / interventions, or their planned administration
- Presence of neovascularisation at the disc in the study eye
- Presence of iris neovascularisation in the study eye
- Uncontrolled glaucoma in the study eye
- Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- Untreated Diabetes Mellitus
- Glycated haemoglobin A (HbA1c) \> 12%
- Uncontrolled hypertension
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04527107
Start Date
July 31 2020
End Date
November 22 2023
Last Update
November 27 2023
Active Locations (78)
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1
Retinal Research Institute, LLC
Phoenix, Arizona, United States, 85053
2
Retina Associates
Tucson, Arizona, United States, 85704
3
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
4
Salehi Retina Institute Inc.
Huntington Beach, California, United States, 92647