ARVO Annual Meeting Abstract | April 2014

Morphological parameters relevant for visual and anatomic outcomes during anti-
VEGF therapy of diabetic macular edema in the RESTORE trial

Bianca Gerendas; Christian Simader; Gabor Gy Deak; Sonja Gudrun Prager; Jan Lammer;
Sebastian M Waldstein; Michael Kundi; Ursula Schmidt-Erfurth
Author Affiliations & Notes
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1791. doi:
Abstract

Purpose: Identification of relevant morphologic factors in multimodal imaging during anti-

VEGF therapy for diabetic macular edema (DME) and prediction of visual and anatomical
outcomes.

Methods: In a subanalysis of a prospective randomized phase III clinical trial, images of

345 patients with DME were systematically analyzed. Patients were randomized to receive
0.5mg Ranibizumab (RZ), 0.5mg Ranibizumab plus laser (RZ+L) or laser alone (L). After
an initial loading phase (LP) of 3 injections in the RZ(+L) arms and one laser treatment at
baseline (BL) in the (RZ+)L arms, patients were treated as needed (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 best corrected visual acuity (BCVA).

Results: At BL mean BCVA was 6410.5 letters (RZ: 65, RZ+L: 63, L: 62); change in
BCVA from BL to month 12 (M12) was 5.510.0 letters (RZ: 7.5, RZ+L: 7.7, L: 0.9).
Mean central retinal thickness (CRT) at BL was 418121m (RZ: 428m, RZ+L: 417m,
L: 409m); change in CRT from BL to M12 was 105123m (RZ: 126m, RZ+L: 126m,
L: 59m). An overall trend for correlation between BCVA gain and CRT decrease was
observed during the LP but lost afterwards. IRC at BL were associated with a lower BL
BCVA in all arms but had no influence on BCVA values at M12; however, patients with
IRC at BL had a larger BCVA gain in RZ which resulted in the same BCVA at M12 for
groups with and without IRC at BL. The same groups showed significantly (p=0.036)
different CRT values at M12: in the group with IRC at BL it was 317m, in the group
without IRC at BL it was 284m. In RZ+L IRC of 380m in height were continuously
associated with significantly (p<0.001) better BCVA from BL to M12. SRF at BL was not
associated with a worse BCVA at BL. However, patients with SRF at BL had a
significantly (p=0.004) higher BCVA gain from BL to M12 in RZ which also resulted in
higher final BCVA levels. No significant impact on BCVA and anatomical outcomes was
found for parameters derived from FA and CF.

Conclusions: Morphologic evaluation of multimodal images may allow predicting

functional and anatomical response to anti-VEGF therapy. In particular, active disease at
BL (i.e. IRC and SRF) is associated with higher BCVA gain, while CRT alone cannot
predict BCVA response.

Keywords: 499 diabetic retinopathy 688 retina 550 imaging/image analysis: clinical