This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period. One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy. It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments. Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Department of Ophthalmology, University Hospital, CHU Dijon
Dijon, France
Department of Ophthalmology, Lariboisière Hospital
Paris, France
Centre d'Investigation Clinique - Centre National d'Ophtalmologie des Quinze-Vingts
Paris, France
Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael
Milan, Italy
Centre for Clinical Trials, Department of Ophthalmology, University of Padova
Padua, Italy
G.B.Bietti Eye Foundation - IRCCS
Rome, Italy
Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Portugal
Espaço Médico de Coimbra
Coimbra, Portugal
Instituto de Retina de Lisboa
Lisbon, Portugal
Serviço de Oftalmologia,Hospital de Vila Franca de Xira
Vila Franca de Xira, Portugal
...and 3 more locations
Regression of neovascularization
Defined as any decrease in the area of neovascularization
Time frame: 12-month treatment
Changes in Best Corrected Visual Acuity (BCVA)
Time frame: 12-Month treatment
Time to complete neovascularization regression
Time frame: 12-Month treatment
Recurrence of neovascularization
Time frame: 12-Month treatment
Macular retinal thickness
Time frame: 12-Month treatment
Need of treatment for Diabetic Macular Edema
Time frame: 12-Month treatment
Need of vitrectomy due to the occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of Diabetic Retinopathy.
Time frame: 12-Month treatment
Adverse events related to the treatments
Time frame: 12-Month treatment
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