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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
Change from baseline in BCVA
Time frame: At Day 84 (Month 3)
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
Number of subjects meeting withdrawal criteria from repeat study treatment
Time frame: At Day 28 and at Day 56
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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
...and 27 more locations