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

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: NCT05063734
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Oxurion

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema Drug: THR-687 dose level 1 Drug: THR-687 dose level 2 Drug: THR-687 selected dose level Drug: Aflibercept Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 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-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Part A, THR-687 dose level 1 Drug: THR-687 dose level 1
3 intravitreal injections of THR-687 dose level 1, 1 month apart

Experimental: Part A, THR-687 dose level 2 Drug: THR-687 dose level 2
3 intravitreal injections of THR-687 dose level 2, 1 month apart

Experimental: Part B, treatment naïve subjects, THR-687 selected dose level Drug: THR-687 selected dose level
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.

Active Comparator: Part B, treatment naïve subjects, aflibercept Drug: Aflibercept
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Other Name: Eylea®

Experimental: Part B, previously treated subjects, THR-687 selected dose level Drug: THR-687 selected dose level
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.

Active Comparator: Part B, previously treated subjects, aflibercept Drug: Aflibercept
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Other Name: Eylea®




Primary Outcome Measures :
  1. Change from Baseline in BCVA ETDRS letter score, at Month 3, in treatment-naïve subjects in Part B of the study [ Time Frame: At Month 3 ]

Secondary Outcome Measures :
  1. Weighted average of the change from Baseline in BCVA ETDRS letter score from Day 8 through Month 3 using the trapezoidal rule (AUC), in treatment-naïve subjects in Part B of the study [ Time Frame: at Month 3 ]
  2. Change from Baseline in BCVA ETDRS letter score, by study visit, in treatment-naïve subjects in Part B of the study [ Time Frame: Up to Month 8 ]
  3. Change from Baseline in Central Subfield Thickness (CST), based on Spectral Domain Optical Coherence Tomography (SD-OCT), as assessed by the Central Reading Center (CRC), by study visit, in treatment-naïve subjects in Part B of the study [ Time Frame: Up to Month 8 ]
  4. Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Month 8 ]


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

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

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): NCT05063734


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
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Responsible Party: Oxurion
ClinicalTrials.gov Identifier: NCT05063734    
Other Study ID Numbers: THR-687-002
2020-000362-42 ( EudraCT Number )
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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