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Completed

NCT Number: NCT04527107

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

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Macular Edema Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Všeobecná fakultní nemocnice v Praze, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THR-149 dose level 1

Drug

3 intravitreal injections of THR-149 dose level 1, 1 month apart

THR-149 dose level 2

Drug

3 intravitreal injections of THR-149 dose level 2, 1 month apart

THR-149 dose level 3

Drug

3 intravitreal injections of THR-149 dose level 3, 1 month apart

THR-149 0.13mg

Drug

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection

THR-149 0.13mg + aflibercept 2mg

Drug

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg

aflibercept 2mg + THR-149 0.13mg

Drug

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)

Aflibercept 2mg

Drug

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Primary outcomes

  1. Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study

    Time frame: At Month 3

Secondary outcomes

  1. Mean change in BCVA ETDRS letter score from Baseline, by study visit

    Time frame: Up to Month 6

  2. Mean change in central subfield thickness (CST) from Baseline, by study visit

    Time frame: Up to Month 6

  3. Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to Month 6

Sponsors and collaborators

Lead sponsor

Oxurion

Industry

Registry information

Official study title

A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

Acronym: KALAHARI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2020
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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