A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

Phase 2

Completed

• Conditions: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Drug: Aflibercept 2mg; Drug: THR-149 dose level 1; Drug: THR-149 dose level 2; Drug: THR-149 dose level 3; Drug: THR-149 0.13mg; Drug: THR-149 0.13mg + aflibercept 2mg; Drug: aflibercept 2mg + THR-149 0.13mg

• Registration Number: NCT04527107
• Lead Sponsor: Oxurion

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. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-31
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-26
• Primary Completion: 2023-09-28
• Status Verified: 2023-11
• Study Completion: 2023-11-22
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept + sham	Aflibercept 2mg	-
THR-149 dose level 1	THR-149 dose level 1	-
THR-149 dose level 2	THR-149 dose level 2	-
THR-149 dose level 3	THR-149 dose level 3	-
THR-149 + sham	THR-149 0.13mg	-
THR-149 + aflibercept flip-over	THR-149 0.13mg + aflibercept 2mg	-
Aflibercept + THR-149 flip-over	aflibercept 2mg + THR-149 0.13mg	-

Primary Outcome Measures

Name	Time	Method
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study	At Month 3

Secondary Outcome Measures

Name	Time	Method
Mean change in BCVA ETDRS letter score from Baseline, by study visit	Up to Month 6
Mean change in central subfield thickness (CST) from Baseline, by study visit	Up to Month 6
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)	Up to Month 6

Trial Locations

Locations (78)

Retinal Research Institute, LLC; 🇺🇸 Phoenix, Arizona, United States

Retina Associates; 🇺🇸 Tucson, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Salehi Retina Institute Inc.; 🇺🇸 Huntington Beach, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.; 🇺🇸 Mountain View, California, United States

California Retina Consultants; 🇺🇸 Oxnard, California, United States

Retina Consultants San Diego; 🇺🇸 Poway, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Retina Consultants of Southern Colorado, P.C.; 🇺🇸 Colorado Springs, Colorado, United States

Blue Ocean Clinical Research; 🇺🇸 Clearwater, Florida, United States

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