Diabetes MellitusPhase 2NCT03499223
A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
A Phase 2 study testing Ranibizumab 0.5mg and THR-317 8mg in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 37 sites in 7 countries.
Trial summary
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
- What is being tested?
- Ranibizumab 0.5mg and THR-317 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 37 sitesin 7 countries
- Study dates
- 20 Apr 2018to 18 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female aged 18 years or older
- Type 1 or type 2 Diabetes Mellitus
- CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
- Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
- Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
- Non-proliferative diabetic retinopathy of any stage in the study eye
- Written informed consent obtained from the subject prior to screening procedures
Who cannot join
- Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
- Any active ocular / intraocular infection or inflammation in either eye
- Aphakic study eye
- Poorly controlled Diabetes Mellitus
- Uncontrolled hypertension
- Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
France10 sites
Centre Rétine Gallien
Bordeaux, 33000
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
CHU Dijon
Dijon, 21079
Hôpital Privé La Louvière
Lille, 59800
Hôpital de la Croix Rousse
Lyon, 69004
Hôpital Saint-Joseph
Marseille, 13285
Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
Nice, 06001
Centre Ophtalmologique de l'Odéon
Paris, 75006
Hôpital Lariboisière
Paris, 75475
Centre Ophtalmologique Maison Rouge
Strasbourg, 67000
Spain8 sites
Centro Médico Téknon
Barcelona, 08022
Hospital Clinic de Barcelona
Barcelona, 08028
Hospital general de Cataluña
Barcelona, 08195
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Vissum Madrid
Madrid, 28002
Hospital General Universitario de Valencia
Valencia, 46014
Oftalvist IMED Valencia
Valencia, 46100
Hospital Universitario Miguel Servet
Zaragoza, 50009
Germany6 sites
Charite Universitaetsmedizin Berlin
Berlin, 12203
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590
Universitaetsklinikum Leipzig
Leipzig, 04103
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, 67063
Philipps-Universität Marburg
Marburg, 35043
Slovakia5 sites
Univerzitná nemocnica Bratislava, Nemocnica Ružinov
Bratislava, 826 06
Univerzitná nemocnica Bratislava, Nemocnica Sv. Cyrila a Metoda
Bratislava, 851 07
Nemocnica Poprad, a.s.
Poprad, 058 01
Fakultná nemocnica Trenčín
Trenčín, 911 71
Fakultná nemocnica s polikliniku Žilina
Žilina, 012 07
United Kingdom5 sites
Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
City Hospitals Sunderland NHS Foundation Trust
Sunderland, SR2 9HP
About this study
Official title: A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
- Being tested
- Ranibizumab 0.5mg, THR-317 8mg, Sham injection
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5mgDrug
Also called Lucentis®
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
THR-317 8mgDrug
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Sham injectionDrug
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab + THR-317 | Experimental | Subjects will receive intravitreal ranibizumab in combination with THR-317 Receives: Drug: Ranibizumab 0.5mg; Drug: THR-317 8mg |
| Sham + ranibizumab | Active comparator | Subjects will receive a sham injection in combination with intravitreal ranibizumab Receives: Drug: Ranibizumab 0.5mg; Drug: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCVA
Measured: At Day 84 (Month 3)
Secondary outcomes (4)
Incidence of systemic and ocular adverse events including serious adverse events
Measured: From Day 0 to Day 140
Change from baseline in BCVA, by study visit
Measured: From Day 0 to Day 140
Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
Measured: From Screening to Day 140
Withdrawal from repeat study treatment and reason for withdrawal
Number of subjects meeting withdrawal criteria from repeat study treatment
Measured: At Day 28 and at Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start20 Apr 2018
- Primary completion18 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxurion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499223
- Sponsor's protocol ID
- THR-317-002
- Other IDs
- 2017-003897-15, 2017
- Status last verified
- Aug 2019
- First submitted
- 4 Apr 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
- ClinicalTrials.gov ID
- NCT03499223
- Acronym / sponsor ID
- THR-317-002
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- OxurionIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
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 evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab + THR-317 | Experimental | Drug: Ranibizumab 0.5mg, Drug: THR-317 8mgSubjects will receive intravitreal ranibizumab in combination with THR-317 |
| Sham + ranibizumab | Active comparator | Drug: Ranibizumab 0.5mg, Drug: Sham injectionSubjects will receive a sham injection in combination with intravitreal ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18 years or older
- Type 1 or type 2 Diabetes Mellitus
- CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
- Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
- Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
Key exclusion criteria (7 listed)
- Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
- Any active ocular / intraocular infection or inflammation in either eye
- Aphakic study eye
- Poorly controlled Diabetes Mellitus
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 |
|---|---|---|
| Ranibizumab 0.5mgAlso: Lucentis®3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart | Drug | Ranibizumab + THR-317, Sham + ranibizumab |
| THR-317 8mg3 intravitreal injections of THR-317 8mg, approximately 1 month apart | Drug | Ranibizumab + THR-317 |
| Sham injection3 sham injections, approximately 1 month apart. No actual injections. No medication is used. | Drug | Sham + ranibizumab |
Primary outcome
Change from baseline in BCVA
Time frame: At Day 84 (Month 3)
4 secondary outcomes
Incidence of systemic and ocular adverse events including serious adverse events
Time frame: From Day 0 to Day 140
Change from baseline in BCVA, by study visit
Time frame: From Day 0 to Day 140
Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit
Time frame: From Screening to Day 140
Withdrawal from repeat study treatment and reason for withdrawal
Time frame: At Day 28 and at Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab 0.5mg and THR-317 8mg in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 37 sites in 7 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France, Spain, Germany, Slovakia, United Kingdom and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: At Day 84 (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 2 Aug 2019.