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Navina trial: diabetic macular edema treated with ranibizumab alone or in combination with other treatments, based on an individualized treatment scheme (phenotype differentiation)

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy IV

Session Date/Time: Sunday 20/09/2015 | 09:00-10:30

Paper Time: 10:12

Venue: Athena.

First Author: : B.PinaMarin SPAIN

Co Author(s): :    M. Fernandezbonet   J. Escobar-Barranco           

Abstract Details

PURPOSE:To describe the functional and anatomic outcome after treatment with Ranibizumab +/- other treatments analysing the outcome according to the origin of the diabetic macular oedema (DME), classified in 3 groups according to their OCT and Fluorescein Angiography (FA) appearance: A) Vasogenic (focal and central origin less than 500 microns from the foveal centre). B) Extrafoveal (origin more than 500 micros from the foveal centre, involving the centre). C) Inflammatory (diffuse with a significant central extravasation component, not good responding after a loading dose of Ranibizumab).


Hospital Dos de Maig. Ophthalmology service


Unicentric study including 60 patients with visual impairment secondary to DME diagnosed. The first 20 patients of each group were included in the study. Minimum follow-up of 12 months. Best corrected visual acuity (BCVA), OCT macular thickness and volume as well as FA profile were recorded. The number of Ranibizumab injections and adjuvant treatments were also recorded in all 3 groups. A treatment scheme was designed specifically for each group, always starting with a loading dose of Ranibizumab: A) Ranibizumab loading dose and follow-up with Pro Re Nata (PRN) Ranibizumab injections. B) Ranibizumab loading dose and deferred focal laser (14-21 days after last injection of loading dose). C) Ranibizumab loading dose plus dexamethasone implant (Ozurdex) and deferred photocoagulation (within 90 days after). The photocoagulation was carried out if peripheral non-perfusion areas were demonstrated with the FA and central focal laser under researcher’s criteria


The mean number of Ranibizumab injections at 12 months in the A group was 6.2; in group B, 4.8 and in group C, 4.7. Dexamethasone implants in group C was 1.7 at 12 months. A BCVA improvement (in ETDRS letters) was recorded in all groups (A: +8.7; B: +7.3; C: +9.7), as well as a decrease in OCT central foveal thickness (microns) (A: -86; B: -155; C: -325). The combination of all three groups showed an increase in visual acuity of+8,6 letters, a decrease in central foveal thickness of -188,6 microns and the mean number of Ranibizumab was 5,2 and Dexamethasone implants 0,6.


Phenotype differentiation of DME may be useful in planning the initial treatment as well as improving the visual and anatomical prognosis. The combination of treatments in group C helps to provide a synergy to stabilize the retina prior to the laser treatment. Differentiating the morphology and pathophysiology of the oedema helps to individualize the treatment.

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