A study to evaluate whether 2 concentrations of THR-317 safely work to treat diabetic macular oedema

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002100-25-HU

Enrollment

Registered

2016-09-01

Start date

2016-11-22

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular oedema (DME) MedDRA version: 20.0 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000015084 MedDRA version: 20.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000015084

Interventions

Product Name: THR-317 8 mg Product Code: THR-317 Pharmaceutical Form: Solution for injection INN or Proposed INN: MONOCLONAL ANTIBODY TB-403 Current Sponsor code: TB-403 Other descriptive name: MONOCL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female aged 18 years or older • Type 1 or type 2 diabetes • Centre-involved DME with central subfield thickness (CST) = 340µm on Spectralis spectral domain optical coherence tomography (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 (20/40 and 20/320 Snellen equivalent) in the study eye • Anti-VEGF treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye • Non-proliferative diabetic retinopathy (NPDR) or stable proliferative diabetic retinopathy (PDR) without neovacularisation at the disc (NVD) • Written informed consent obtained from the subject prior to screening procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: • 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 as listed below or their planned use during the THR-317 treatment period for up to 30 days after the last injection Treatment / Procedure in Excluded Period prior to the Study Eye Visit 2 (Day 0) Panretinal or focal / grid laser 3 months photocoagulation 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 4 months corticosteroids 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4mg or 8mg) and to assess its efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with centre-involved DME;Secondary Objective: Not applicable;Primary end point(s): • 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;Timepoint(s) of evaluation of this end point: up to 7-day follow-up visit after each injection	—

Measure

Time frame

Main Objective: To evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4mg or 8mg) and to assess its efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with centre-involved DME;Secondary Objective: Not applicable;Primary end point(s): • 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;Timepoint(s) of evaluation of this end point: up to 7-day follow-up visit after each injection

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Secondary

Measure	Time frame
Secondary end point(s): • Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject • Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150 • Proportion of subjects withdrawn from repeat injection and reason for withdrawal • Proportion of subjects with a loss of = 15, = 10 or = 5 ETDRS letters in BCVA from baseline by study visit • 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 • Proportion of subjects with a = 15 ETDRS letters gain in BCVA from baseline or = 83 ETDRS letters, by study visit • Mean change from baseline in BCVA, by study visit • Mean change from baseline in CST, by study visit, based on SD-OCT;Timepoint(s) of evaluation of this end point: from baseline to end of study	—

Measure

Time frame

Secondary end point(s): • Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject • Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150 • Proportion of subjects withdrawn from repeat injection and reason for withdrawal • Proportion of subjects with a loss of = 15, = 10 or = 5 ETDRS letters in BCVA from baseline by study visit • 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 • Proportion of subjects with a = 15 ETDRS letters gain in BCVA from baseline or = 83 ETDRS letters, by study visit • Mean change from baseline in BCVA, by study visit • Mean change from baseline in CST, by study visit, based on SD-OCT;Timepoint(s) of evaluation of this end point: from baseline to end of study

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Countries

Czech Republic, Hungary, Slovakia

Contacts

Public ContactGlobal Clinical Development

ThromboGenics NV

info@thrombogenics.com3216751310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026