RHINE – Phase III study in the treatment of diabetic macular oedema 08/05/2019
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This is a phase III, multi-centre, randomised, double-masked, three-group trial that assesses the efficacy and safety of RG7716 administered through intravitreal injections in adult patients with visual disturbance due to diabetic macular oedema (DMO) in comparison with the administration of aflibercept (EYLEA®).
Principal inclusion criteria:
Patients of over 18 years of age with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular oedema in the study eye without previous treatment with any anti-VEGF drug or who have not received it in the past three months.
Visual acuity should be between 20/32 and 20/320.
The main aim is to demonstrate that RG7716 is not inferior to aflibercept with respect to visual outcome after the first year of treatment.
About the drug:
RG7716 is an antibody that inhibits for the first time and simultaneously two factors, VEGF-A and Angiopoietin 2, producing a priori improved control of the mechanisms that induce diabetic macular oedema.
This trial has a duration of two years.
*Institut Registration Code: E08607500. Clinical trial authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the CEIm of the Quironsalud Hospital Group in Barcelona.