Diabetic RetinopathyPhase 2NCT03071068
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
A Phase 2 study testing Anti-PlGF recombinant monoclonal antibody, 4mg dose and Anti-PlGF recombinant monoclonal antibody, 8mg dose in people with Diabetic Retinopathy and Macular Edema, run by ThromboGenics at 13 sites in 3 countries.
Trial summary
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- Anti-PlGF recombinant monoclonal antibody, 4mg dose and Anti-PlGF recombinant monoclonal antibody, 8mg dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 22 Dec 2016to Apr 2018
- 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
- Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye
- Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye
- Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
- Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc
- Written informed consent obtained from the subject prior to screening procedures
Who cannot join
- Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation [3 months], anti-VEGF treatment [any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment], intra-ocular or peri-ocular corticosteroids [4 months], steroid implant [any time], intra-ocular surgery [3 months], vitrectomy [any time]
- Any active ocular / intra-ocular infection or inflammation in either eye
- Aphakic study eye
- Untreated diabetes
- Glycated haemoglobin A (HbA1c) > 12%
- Uncontrolled hypertension in the opinion of the Investigator
- 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 suggesting lens / zonular instability
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Hungary5 sites
Study site
Budapest, 1083
Study site
Budapest, 1133
Study site
Debrecen, 4032
Study site
Pécs, 7621
Study site
Szeged, 6720
Czechia4 sites
Study site
Brno, 625 00
Study site
Hradec Králové, 500 05
Study site
Prague, 100 34
Study site
Prague, 180 00
Slovakia4 sites
Study site
Bratislava, 826 06
Study site
Bratislava, 851 07
Study site
Trenčín, 911 71
Study site
Žilina, 012 07
About this study
Official title: A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- Anti-PlGF recombinant monoclonal antibody, 4mg dose, Anti-PlGF recombinant monoclonal antibody, 8mg dose
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PlGF recombinant monoclonal antibody, 4mg doseDrug
3 intravitreal injections of THR-317 4mg approximately 1 month apart
Anti-PlGF recombinant monoclonal antibody, 8mg doseDrug
3 intravitreal injections of THR-317 8mg approximately 1 month apart
| Study group | Role | What they receive |
|---|---|---|
| THR-317 4mg | Experimental | anti-PlGF recombinant monoclonal antibody, 4mg dose Receives: Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose |
| THR-317 8mg | Experimental | anti-PlGF recombinant monoclonal antibody, 8mg dose Receives: Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject
Measured: up to the 7-day follow-up visit after each injection
Secondary outcomes (8)
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
Measured: up to the 30-day follow-up visit after each injection
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
Measured: From day 0 to day 150
Proportion of subjects withdrawn from repeat injection and reason for withdrawal
Measured: At day 30 and at day 60
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
Measured: Up to day 150
Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection
Measured: Up to 7-day follow-up visit after each injection
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
Measured: Up to day 150
Mean change from baseline in BCVA, by study visit
Measured: Up to day 150
Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)
Measured: Up to day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start22 Dec 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Department, Study director, ThromboGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071068
- Sponsor's protocol ID
- THR-317-001
- Other IDs
- 2016-002100-25, 2016
- Status last verified
- Apr 2018
- First submitted
- 21 Feb 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
- ClinicalTrials.gov ID
- NCT03071068
- Acronym / sponsor ID
- THR-317-001
- Conditions
- Diabetic Retinopathy, Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 6 Mar 2017 (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 THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THR-317 4mg | Experimental | Drug: Anti-PlGF recombinant monoclonal antibody, 4mg doseanti-PlGF recombinant monoclonal antibody, 4mg dose |
| THR-317 8mg | Experimental | Drug: Anti-PlGF recombinant monoclonal antibody, 8mg doseanti-PlGF recombinant monoclonal antibody, 8mg dose |
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
- Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye
- Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye
- Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
Key exclusion criteria (8 listed)
- Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation [3 months], anti-VEGF treatment [any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment], intra-ocular or peri-ocular corticosteroids [4 months], steroid implant [any time], intra-ocular surgery [3 months], vitrectomy [any time]
- Any active ocular / intra-ocular infection or inflammation in either eye
- Aphakic study eye
- Untreated diabetes
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 |
|---|---|---|
| Anti-PlGF recombinant monoclonal antibody, 4mg dose3 intravitreal injections of THR-317 4mg approximately 1 month apart | Drug | THR-317 4mg |
| Anti-PlGF recombinant monoclonal antibody, 8mg dose3 intravitreal injections of THR-317 8mg approximately 1 month apart | Drug | THR-317 8mg |
Primary outcome
Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject
Time frame: up to the 7-day follow-up visit after each injection
8 secondary outcomes
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
Time frame: up to the 30-day follow-up visit after each injection
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
Time frame: From day 0 to day 150
Proportion of subjects withdrawn from repeat injection and reason for withdrawal
Time frame: At day 30 and at day 60
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
Time frame: Up to day 150
Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection
Time frame: Up to 7-day follow-up visit after each injection
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
Time frame: Up to day 150
Mean change from baseline in BCVA, by study visit
Time frame: Up to day 150
Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)
Time frame: Up to day 150
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 17 Apr 2018.
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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
ThromboGenics
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-PlGF recombinant monoclonal antibody, 4mg dose and Anti-PlGF recombinant monoclonal antibody, 8mg dose in people with Diabetic Retinopathy and Macular Edema, run by ThromboGenics at 13 sites in 3 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 8 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Hungary, Czechia, Slovakia. 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?
Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject (time frame: up to the 7-day follow-up visit after each injection). 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 17 Apr 2018.