A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedema

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003897-15-ES

Enrollment

Registered

2018-01-18

Start date

2018-04-03

Completion date

Unknown

Last updated

2019-12-10

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: 20.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853 MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Interventions

Product Name: THR-317 8 mg Product Code: THR-317 Pharmaceutical Form: Solution for injection INN or Proposed INN: Monoclonal antibody TG-403

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female aged 18 years or older - Type 1 or type 2 diabetes - CI-DME with central subfield thickness of = 320µm on Spectralis® SD-OCT or = 305µm on non-Spectralis SD-OCT, in the study eye - 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 (NPDR) of any stage in the study eye - 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 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

Exclusion criteria: - Macular oedema due to causes other than DME - 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 - Change of the retinal architecture in the centre of the macula of the study eye that is likely to preclude improvement in BCVA following the resolution of DME - Previous treatments / procedures as listed below, or their planned / expected use during the study period for up to 30 days after the last study treatment: * Ranibizumab treatment in the study eye (any time for anti-VEGF naïve subjects; 1 month for subjects with a poor or no response to ranibizumab treatment) * Bevacizumab treatment in the study eye (any time for anti-VEGF naïve subjects; 3 months for subjects with a poor or no response to ranibizumab treatment) * Aflibercept treatment in the study eye (any time) * Intraocular surgery in the study eye (3 months) * Focal / grid laser photocoagulation in the study eye (3 months) * Panretinal laser photocoagulation in the study eye (6 months) * Intraocular or peri-ocular corticosteroids in the study eye (4 months) * Ozurdex® (dexamethasone intravitreal implant) in the study eye (6 months) * Other steroid implant in the study eye (any time) * Systemic anti-VEGF treatment (3 months) * Systemic corticosteroids (3 months) - Aphakic study eye - Uncontrolled glaucoma in the study eye - More than 8D high myopia in the study eye - Any active ocular / intraocular infection or inflammation in either eye - Untreated diabetes - Glycated haemoglobin A (HbA1c) > 12% - Uncontrolled hypertension in the opinion of the Investigator - Pregnant or lactating female - Female of child-bearing potential not utilising an adequate form of contraception, or planning to become pregnant or to discontinue contraceptive precautions at any time during the entire study period - Male of reproductive potential not utilising contraception

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of THR-317 administered in combination with ranibizumab, in subjects with central-involved DME (CI-DME);Secondary Objective: Not applicable;Primary end point(s): Change from baseline in BCVA;Timepoint(s) of evaluation of this end point: Day 84 (Month 3)	—

Secondary

Measure	Time frame
Secondary end point(s): - Incidence of systemic and ocular (serious) adverse events ([S]AEs), from first administration of study treatment up to the end of the study - Change from baseline in BCVA, by study visit - Change from baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit - Withdrawal from repeat study treatment and reason for withdrawal ;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study	—

Measure

Time frame

Secondary end point(s): - Incidence of systemic and ocular (serious) adverse events ([S]AEs), from first administration of study treatment up to the end of the study - Change from baseline in BCVA, by study visit - Change from baseline in CST, based on SD-OCT, as assessed by the CRC, by study visit - Withdrawal from repeat study treatment and reason for withdrawal ;Timepoint(s) of evaluation of this end point: From first administration of study treatment up to end of study

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Countries

Belgium, France, Germany, Slovakia, Spain, United Kingdom

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