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

Oxurion

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema; Diabetes Mellitus; Diabetic Retinopathy

Treatments: Drug: THR-149 dose level 2; Drug: THR-149 0.13mg; Drug: THR-149 0.13mg + aflibercept 2mg; Drug: THR-149 dose level 1; Drug: THR-149 dose level 3; Drug: Aflibercept 2mg; Drug: aflibercept 2mg + THR-149 0.13mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04527107

2019-001506-17 (EudraCT Number)

THR-149-002

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 7 patient groups

THR-149 dose level 1

Experimental group

Treatment:

Drug: THR-149 dose level 1

THR-149 dose level 2

Experimental group

Treatment:

Drug: THR-149 dose level 2

THR-149 dose level 3

Experimental group

Treatment:

Drug: THR-149 dose level 3

THR-149 + sham

Experimental group

Treatment:

Drug: THR-149 0.13mg

THR-149 + aflibercept flip-over

Experimental group

Treatment:

Drug: THR-149 0.13mg + aflibercept 2mg

Aflibercept + THR-149 flip-over

Active Comparator group

Treatment:

Drug: aflibercept 2mg + THR-149 0.13mg

Aflibercept + sham

Active Comparator group

Treatment:

Drug: Aflibercept 2mg