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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527107
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Oxurion

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema 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 Drug: Aflibercept 2mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 31, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Aflibercept

Arms and Interventions
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Arm Intervention/treatment
Experimental: THR-149 dose level 1 Drug: THR-149 dose level 1
3 intravitreal injections of THR-149 dose level 1, 1 month apart
Experimental: THR-149 dose level 2 Drug: THR-149 dose level 2
3 intravitreal injections of THR-149 dose level 2, 1 month apart
Experimental: THR-149 dose level 3 Drug: THR-149 dose level 3
3 intravitreal injections of THR-149 dose level 3, 1 month apart
Experimental: THR-149 + sham Drug: THR-149 0.13mg
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
Experimental: THR-149 + aflibercept flip-over Drug: THR-149 0.13mg + aflibercept 2mg
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
Active Comparator: Aflibercept + THR-149 flip-over Drug: aflibercept 2mg + THR-149 0.13mg
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)
Active Comparator: Aflibercept + sham Drug: Aflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527107


Contacts
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Contact: Global Clinical Development +32 (0)16 751 310 info@oxurion.com

Locations
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Sponsors and Collaborators
Oxurion
Investigators
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Study Director: Clinical Department Oxurion
More Information
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Responsible Party: Oxurion
ClinicalTrials.gov Identifier: NCT04527107    
Other Study ID Numbers: THR-149-002
2019-001506-17 ( EudraCT Number )
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Aflibercept
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents