March 2017
Volume 58, Issue 3
Open Access
Letters to the Editor  |   March 2017
Author Response: Functional and Anatomic Outcomes in Patients With Serous Retinal Detachment in Diabetic Macular Edema Treated With Ranibizumab
Author Affiliations & Notes
  • Audrey Giocanti-Auregan
    Department of Ophthalmology, Hôpital Avicenne, Bobigny, France;
    DHU Vision et Handicap, Department of Ophthalmology, Hôpital Pitié-Salpêtrière, Paris; and from
  • Franck Fajnkuchen
    Department of Ophthalmology, Hôpital Avicenne, Bobigny, France;
    DHU Vision et Handicap, Department of Ophthalmology, Hôpital Pitié-Salpêtrière, Paris; and from
    Centre Ophtalmologique d'Imagerie et de Laser, France.
Investigative Ophthalmology & Visual Science March 2017, Vol.58, 1857. doi:10.1167/iovs.17-21726
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      Audrey Giocanti-Auregan, Franck Fajnkuchen; Author Response: Functional and Anatomic Outcomes in Patients With Serous Retinal Detachment in Diabetic Macular Edema Treated With Ranibizumab. Invest. Ophthalmol. Vis. Sci. 2017;58(3):1857. doi: 10.1167/iovs.17-21726.

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      © ARVO (1962-2015); The Authors (2016-present)

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We appreciate the interest of Ashraf1 in our recent publication of outcomes from the Ophthalmology Department of Avicenne Hospital in France, entitled “Functional and anatomical outcomes in patients with serous retinal detachment in diabetic macular edema treated with ranibizumab.”2 
We agree with several of his assertions, but we would like to clarify some points that we developed in our discussion. 
We agree that the post hoc analysis of the RISE and RIDE studies3 on the impact of subretinal detachment (SRD) in diabetic macular edema (DME) showed that patients with SRD treated monthly with ranibizumab were more likely to achieve a final visual acuity (VA) of >20/40 in contrast with patients with SRD in the sham group, who were more likely to achieve a low final VA of <20/100. We did not dispute these results. However, our study found the same visual gain in both groups (with or without SRD), which is why we carefully concluded that “SRD does not seem to be a good prognostic factor during DME treatment with ranibizumab with a PRN regimen and in a real-life setting.” Also, we would like to insist on the fact that we used a PRN regimen based on VA in a real-life setting, involving, as Ashraf1 suggested, a potential undertreatment of our patients (between 5.2 and 5.5 injections over 1 year) versus 12 injections in RISE and RIDE studies.4 However, our number of intravitreal injections over the first year, although low, is consistent with those reported in previous real-life studies (5.45–7.26 injections over the first year). Like Ashraf,1 we are convinced that SRD could be a good visual outcome prognostic indicator under monthly ranibizumab therapy, and a poor prognostic factor resulting in severe visual loss in patients who do not receive anti-VEGF3,7 or any DME treatment, and our patients with SRD probably would have needed more injections to significantly improve their VA compared to patients with DME without SRD. 
Regarding our results, Ashraf1 considered our SRD+ group as undertreated before inclusion, because the eyes received less laser photocoagulation. However, we only performed focal photocoagulation in case of extracentral macular edema with vision loss threat in these eyes (no grid), before they experienced central edema with vision loss, or 6 months after initiation of intravitreal treatment if the extracentral edema still was present. So, we considered that if patients received less laser in the SRD+ group, this means that they would have less needed laser, and this is not undertreatment but a lower need for treatment in this case. Also, for more accuracy about the type of edema, we would like to specify that all our eyes included had central cystoid macular edema associated or not with SRD, and not diffuse edema, and, thus, both groups were homogeneous regarding this parameter. 
Another major interesting point highlighted by Ashraf1 is that our retreatment criteria were based only on VA and if we had used a protocol based on visual and anatomic parameters to guide retreatment, SRD would have been associated with better visual outcomes. However, at the time of the study we followed the European guidelines8 based on the results of the RESTORE study,9 recommending retreatment based on VA outcomes. We agree on this point with Ashraf1 and our results support it, with still 26.5% of SRD persisting after 1 year of follow-up despite treatment, for which a more aggressive treatment would have been beneficial. 
Finally, our study was retrospective and not a prospective randomized controlled trial. This design has some limitations and we were not able to match our patients on anatomic predictive factors, such as disorganization of inner retinal layers (DRIL).10 However, the regression of the DRIL size correlated with a better visual improvement, and we focused on baseline predictive factors rather than on evolving factors, such as DRIL. Moreover, we agree that since no large prospective studies assessing predictive factors of response to anti-VEGF in DME are available, but only retrospective studies or post hoc analyses, and since there is no real consensus on the subject, prospective studies taking into account the need to control important anatomical parameters, such as DRIL for instance, are needed. 
References
Ashraf M. Functional and anatomic outcomes in patients with serous retinal detachment in diabetic macular edema treated with ranibizumab. Invest Ophthalmol Vis Sci. 2017; 58: 1856.
Giocanti-Aurégan A, Hrarat L, Qu LM, et al. Functional and anatomical outcomes in patients with serous retinal detachment in diabetic macular edema treated with ranibizumab. Invest Ophthalmol Vis Sci. 2017; 58: 797–800.
Sophie R, Lu N, Campochiaro PA. Predictors of functional and anatomic outcomes in patients with diabetic macular edema treated with ranibizumab. Ophthalmology. 2015; 122: 1395–1401.
Brown DM, Nguyen QD, Marcus DM, et al. Long-term outcomes of ranibizumab therapy for diabetic macular edema: the 36-month results from two phase III trials: RISE and RIDE. Ophthalmology. 2013; 120: 2013–2022.
Hrarat L, Fajnkuchen F, Boubaya M, et al. Outcomes after a 1-year treatment with ranibizumab for diabetic macular edema in a clinical setting. Ophthalmologica. 2016; 236: 207–214.
Patrao NV, Antao S, Egan C, et al. Real-world outcomes of ranibizumab treatment for diabetic macular edema in a United Kingdom National Health Service setting. Am J Ophthalmol. 2016; 172: 51–57.
Ashraf M, Souka A, Adelman R. Predicting outcomes to anti-vascular endothelial growth factor (VEGF) therapy in diabetic macular oedema: a review of the literature. Br J Ophthalmol. 2016; 100: 1596–1604.
Bandello F, Cunha-Vaz J, Chong NV, et al. New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel. Eye Lond Engl. 2012; 26: 485–493.
Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011; 118: 615–625.
Sun JK, Lin MM, Lammer J, et al. Disorganization of the retinal inner layers as a predictor of visual acuity in eyes with center-involved diabetic macular edema. JAMA Ophthalmol. 2014; 132: 1309–1316.
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