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Bianca S. Gerendas, Sonja Gudrun Prager, Gabor Gyoergy Deak, Sebastian M Waldstein, Jan Lammer, Christian Simader, Michael Kundi, Ursula Schmidt-Erfurth; Morphological parameters relevant for long-term outcomes during therapy of diabetic macular edema in the RESTORE Extension trial. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4686.
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© ARVO (1962-2015); The Authors (2016-present)
Identification of morphologic factors in multimodal imaging during therapy of diabetic macular edema (DME) and long-term prediction of visual and anatomical outcomes after 3 years.
In a subanalysis of a prospective randomized phase III clinical trial, images of 345 patients with DME were analyzed. Patients were randomized to receive 0.5mg Ranibizumab (RBZ), 0.5mg RBZ plus laser or laser alone from baseline (BL) to month (M) 12. After an initial loading phase of 3 injections or one laser treatment, patients were treated as needed (PRN). From M13 to M36 all patients received RBZ PRN. After standardized image evaluation at the Vienna Reading Center parameters of optical coherence tomography (OCT), fluorescein angiography (FA) and color fundus (CF) images were correlated with (change of) best corrected visual acuity (BCVA) from BL to M12 and M36.
On OCT intraretinal cysts (IRC) were present in 94% of patients at BL. IRC disappeared rapidly under RBZ treatment. With laser mono-therapy they did not disappear by M12, however with PRN RBZ by M36. There was no difference in IRC location as seen on OCT (outer or inner nuclear layer) between the study arms until M36. On OCT subretinal fluid (SRF) was present in 23% of patients at BL. It was not associated with a worse BCVA at BL, disappeared in all arms by M12, and did not relapse by M36. A trend towards higher BCVA gains from BL to M36 was seen in patients with SRF at BL treated with RBZ. In the laser arm patients with SRF at BL lost BCVA until M12, whereas patients without SRF remained stable; in the combination arm all patients gained BCVA. Patients with SRF at BL showed a significantly higher decrease of central retinal thickness at M12/M36 under RBZ therapy. No significant impact on BCVA and anatomical outcomes was found for parameters graded on FA and CF images until M12. However, signs of diabetic retinopathy (DR) in FA/CF (microaneuryms, hemorrhage, hard exudates) were significantly reduced by M36 in all arms.
Biomarkers assessed from multimodal images may allow to predict functional and anatomical therapy response in DME. In particular, IRC are rapidly amenable to resolution after RBZ treatment as opposed to laser mono-therapy. Presence of SRF at BL tends to predict higher BCVA gains if treated with RBZ and signs of DR can be significantly reduced under PRN RBZ treatment after 3 years.
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