A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema. (INTEGRAL)

Oxurion

Status and phase: Terminated; Phase 2

Conditions: Diabetic Macular Edema; Diabetes Mellitus; Diabetic Retinopathy

Treatments: Drug: THR-687 dose level 2; Drug: Aflibercept; Drug: THR-687 selected dose level; Drug: THR-687 dose level 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05063734

THR-687-002

2020-000362-42 (EudraCT Number)

Details and patient eligibility

About

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Full description

In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg.

In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

All subjects in the study will receive study treatment in one selected study eye only.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The subjects in this study will be subjects with central-involved DME (CI-DME). Both treatment-naïve and previously treated subjects will be included.

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 ≥ 39 in the study eye
• CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
• BCVA ETDRS letter score ≥ 34 in the fellow eye

Exclusion Criteria:

• Macular edema due to causes other than DME in the study eye
• Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
• Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
• Previous confounding medications / interventions, or their planned administration during the study
• Presence of iris neovascularisation in the study eye
• Uncontrolled glaucoma in the study eye
• Previously received THR-687 or any other experimental therapy for DME, in either eye
• Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
• Untreated Diabetes
• 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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16 participants in 6 patient groups

Part A, THR-687 1.2 mg

Experimental group

Treatment:

Drug: THR-687 dose level 1

Part A, THR-687 2.0mg

Experimental group

Treatment:

Drug: THR-687 dose level 2

Part B, treatment naïve subjects, THR-687 selected dose level

Experimental group

Description:

Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected

Treatment:

Drug: THR-687 selected dose level

Part B, treatment naïve subjects, aflibercept 2.0mg

Active Comparator group

Treatment:

Drug: Aflibercept

Part B, previously treated subjects, THR-687 selected dose level

Experimental group

Description:

Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected

Treatment:

Drug: THR-687 selected dose level

Part B, previously treated subjects, aflibercept 2.0mg

Active Comparator group

Treatment:

Drug: Aflibercept