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Introduction: Diabetic retinopathy is one of the first cause of visual acuity impairment. The aim of this protocol is to investigate the decrease of neovascularization on fluorescein angiography after intravitreal aflibercept (2mg) compared to pan-retinal photocoagulation (PRP) for the treatment of non-complicated proliferative diabetic retinopathy (PDR) without diabetic macular edema (DME).

Methods: Prospective comparative II phase study (NTC02151695) including diabetic patient with noncomplicated PDR on one eye. The inclusion criteria are the best visual acuity score superior or equal to 35 letters, glycosylated hemoglobin less 11.6% and DME less than 350 microns one study eye. The pre-retinal or pre-papillary endovascular area is assessed by fluorescein angiography with ultra wide field imaging (Spectral is®, Heidelberg engineering) in PDR between baseline and month 12, compared to PRP with picture at 3 minutes in study eye. For the second criteria of efficacy, Spectral Domain-OCT (SD-OCT) scans centered on the macular area is performed at months 3, 6 and 12.

Other criteria include follow-up of the retinal neovascularization in fluorescein angiography between the baseline, the month 3 and 6, the follow-up of the best visual corrected acuity (EDTRS scale) in the first year and the proportion of vasectomy for persistent vitreous hemorrhage or tractional retinal detachment at month 3, 6 and 12. Any local adverse event or systemic adverse event are recorded during the follow-up.

Conclusion: Today, some studies show intravitreal anti-vascular endothelial growth factor (VEGF) injection reduce the PDR according to Early Treatment Diabetic Retinopathy Study (ETDRS) classification but no with fluorescein angiography. The results of this trial will permit to study more precisely the evolution of neovascularization between the two groups.

Rameau (langage normalisé) :
• Rétinopathie diabétique -- Thérapeutique