Diabetes MellitusPhase 2INTEGRALNCT05063734
A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
A Phase 2 study testing THR-687 dose level 1, THR-687 dose level 2 and THR-687 selected dose level in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 25 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- THR-687 dose level 1, THR-687 dose level 2 and THR-687 selected dose level
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 27 Aug 2021to 29 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States18 sites
Austin Research Center of Retina
Austin, Texas, 78705
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, 80909
Retina Associates, Ltd
Elmhurst, Illinois, 60126
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Salehi Retina Institute Inc.
Huntington Beach, California, 92647
Retina Consultants of Texas
Katy, Texas, 77494
Eye Care Specialists
Kingston, Pennsylvania, 18704
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, 13088
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Tennessee Retina, PC
Nashville, Tennessee, 37203
University Retina and macula Associates, PC
Oak Forest, Illinois, 60452
California Eye Specialists Medical Group, Inc.
Pasadena, California, 91107
Sierra Eye Associates
Reno, Nevada, 89502
Retinal Consultants Medical Group
Sacramento, California, 95825
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Retina Center of Texas
Southlake, Texas, 76092
Tulsa Retina Consultants
Tulsa, Oklahoma, 74114
Strategic Clinical Research Group
Willow Park, Texas, 76087
Estonia2 sites
Eye Clinic Dr Krista Turman
Tallinn, 11314
Silmalaser OU
Tallinn, 11412
Hungary2 sites
Ganglion Medical Center
Pécs, 7621
Szegedi Tudományegyetem
Szeged, 6720
Latvia2 sites
Pauls Stradins Clinical University Hospital
Riga, LV-1002
Riga East Clinical University Hospital
Riga, LV-1006
Lithuania1 site
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661
About this study
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)
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).
Read the detailed 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.
- Being tested
- THR-687 dose level 1, THR-687 dose level 2, THR-687 selected dose level, Aflibercept
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR-687 dose level 1Drug
3 intravitreal injections of THR-687 dose level 1, 1 month apart
THR-687 dose level 2Drug
3 intravitreal injections of THR-687 dose level 2, 1 month apart
THR-687 selected dose levelDrug
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.
AfliberceptDrug
Also called Eylea®
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A, THR-687 1.2 mg | Experimental | Not described Receives: Drug: THR-687 dose level 1 |
| Part A, THR-687 2.0mg | Experimental | Not described Receives: Drug: THR-687 dose level 2 |
| Part B, treatment naïve subjects, THR-687 selected dose level | Experimental | Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected Receives: Drug: THR-687 selected dose level |
| Part B, treatment naïve subjects, aflibercept 2.0mg | Active comparator | Not described Receives: Drug: Aflibercept |
| Part B, previously treated subjects, THR-687 selected dose level | Experimental | Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected Receives: Drug: THR-687 selected dose level |
| Part B, previously treated subjects, aflibercept 2.0mg | Active comparator | Not described Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
Measured: At Month 3
Secondary outcomes (4)
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
Measured: at Month 3
Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Measured: 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
Measured: Up to Month 8
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events will be reported from the date of Informed Consent until End of the Study visit (up to Month 6 in Part A and up to Month 8 in Part B) or at the early study discontinuation visit and will be coded using MedDRA. Adverse Events will be summarized by System Organ Class and Primary Term. Incidence by subject represents at least one occurrence of the Primary Term with an onset on or after the date of the first study treatment. If a subject has multiple occurrences of an adverse event (P-term), the subject is presented only once in the respective subject count.
Measured: Up to End of Study (Part A up to Month 6 and Part B up to Month 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start27 Aug 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Why it stopped: Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxurion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Department, Study director, Oxurion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063734
- Sponsor's protocol ID
- THR-687-002
- Other IDs
- 2020-000362-42
- Acronym
- INTEGRAL
- Status last verified
- Jul 2023
- First submitted
- 8 Sep 2021
- Last updated
- 18 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05063734
- Acronym / sponsor ID
- INTEGRAL / THR-687-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on data obtained in Part A, there was insufficient evidence of efficacy on the key outcome measures. As a result, the study was not advanced to Part B.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- OxurionIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 18 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A, THR-687 1.2 mg | Experimental | Drug: THR-687 dose level 1 |
| Part A, THR-687 2.0mg | Experimental | Drug: THR-687 dose level 2 |
| Part B, treatment naïve subjects, THR-687 selected dose level | Experimental | Drug: THR-687 selected dose levelDue to the discontinuation of the study after Part A, the dose level for Part B has not been selected |
| Part B, treatment naïve subjects, aflibercept 2.0mg | Active comparator | Drug: Aflibercept |
| Part B, previously treated subjects, THR-687 selected dose level | Experimental | Drug: THR-687 selected dose levelDue to the discontinuation of the study after Part A, the dose level for Part B has not been selected |
| Part B, previously treated subjects, aflibercept 2.0mg | Active comparator | Drug: Aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THR-687 dose level 13 intravitreal injections of THR-687 dose level 1, 1 month apart | Drug | Part A, THR-687 1.2 mg |
| THR-687 dose level 23 intravitreal injections of THR-687 dose level 2, 1 month apart | Drug | Part A, THR-687 2.0mg |
| THR-687 selected dose level3 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. | Drug | Part B, previously treated subjects, THR-687 selected dose level, Part B, treatment naïve subjects, THR-687 selected dose level |
| AfliberceptAlso: Eylea®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. | Drug | Part B, previously treated subjects, aflibercept 2.0mg, Part B, treatment naïve subjects, aflibercept 2.0mg |
Primary outcome
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
4 secondary outcomes
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 End of Study (Part A up to Month 6 and Part B up to Month 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Department study director
Oxurion
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THR-687 dose level 1, THR-687 dose level 2 and THR-687 selected dose level in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Estonia, Hungary, Latvia, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.