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A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)

Phase 2
Completed
Conditions
Diabetic Retinopathy
Macular Edema
Diabetes Mellitus
Interventions
Drug: THR-317 8mg
Drug: Sham injection
Registration Number
NCT03499223
Lead Sponsor
Oxurion
Brief 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 oedema (CI-DME).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham + ranibizumabRanibizumab 0.5mgSubjects will receive a sham injection in combination with intravitreal ranibizumab
Ranibizumab + THR-317THR-317 8mgSubjects will receive intravitreal ranibizumab in combination with THR-317
Ranibizumab + THR-317Ranibizumab 0.5mgSubjects will receive intravitreal ranibizumab in combination with THR-317
Sham + ranibizumabSham injectionSubjects will receive a sham injection in combination with intravitreal ranibizumab
Primary Outcome Measures
NameTimeMethod
Change from baseline in BCVAAt Day 84 (Month 3)
Secondary Outcome Measures
NameTimeMethod
Change from baseline in BCVA, by study visitFrom 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 visitFrom Screening to Day 140
Withdrawal from repeat study treatment and reason for withdrawalAt Day 28 and at Day 56

Number of subjects meeting withdrawal criteria from repeat study treatment

Incidence of systemic and ocular adverse events including serious adverse eventsFrom Day 0 to Day 140

Trial Locations

Locations (37)

CHU Brugmann

🇧🇪

Brussels, Belgium

UZ Leuven

🇧🇪

Leuven, Belgium

Centre Rétine Gallien

🇫🇷

Bordeaux, France

Centre Hospitalier Intercommunal de Créteil

🇫🇷

Créteil, France

CHU Dijon

🇫🇷

Dijon, France

Hôpital Privé La Louvière

🇫🇷

Lille, France

Hôpital de la Croix Rousse

🇫🇷

Lyon, France

Hôpital Saint-Joseph

🇫🇷

Marseille, France

Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

🇫🇷

Nice, France

Centre Ophtalmologique de l'Odéon

🇫🇷

Paris, France

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CHU Brugmann
🇧🇪Brussels, Belgium

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