A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema. (INTEGRAL)
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| ClinicalTrials.gov Identifier: NCT05063734 |
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Recruitment Status :
Recruiting
First Posted : October 1, 2021
Last Update Posted : April 11, 2022
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Sponsor:
Oxurion
Information provided by (Responsible Party):
Oxurion
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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 |
| 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 |
| 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 :
- 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 :
- 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 ]
- 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 ]
- 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 ]
- Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Month 8 ]
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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
| Contact: Global Clinical Development | +32 (0)16 751 310 | info@oxurion.com |
Locations
Show 27 study locations
Sponsors and Collaborators
Oxurion
Investigators
| Study Director: | Clinical Department | Oxurion |
| 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 |
| 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 |