Relation between macular morphology and treatment frequency during twelve months with ranibizumab for diabetic macular edema.

Yuki Mori,Tomoaki Murakami,Kiyoshi Suzuma,Kenji Ishihara,Masahiro Fujimoto,Akitaka Tsujikawa,Shin Yoshitake,Yoko Dodo,Yuko Miwa,Tatsuya Yoshitake

doi:10.1371/journal.pone.0175809

Yuki Mori, Tomoaki Murakami + Show 8 more

Open Access

https://doi.org/10.1371/journal.pone.0175809

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Journal: PloS one	Publication Date: Apr 13, 2017
Citations: 16	License type: CC BY 4.0

Affiliation: Kyoto University

Abstract

PurposeTo investigate whether baseline optical coherence tomography (OCT) parameters can predict the treatment frequency of intravitreal ranibizumab (IVR) injections during the first year in patients with diabetic macular edema (DME) treated with pro re nata (PRN) IVR injections.MethodsWe retrospectively reviewed 68 eyes of 63 patients with center-involved DME who received IVR injections for 12 months or longer according to three monthly IVR injections followed by the PRN dosing. We measured the mean retinal thicknesses in the individual subfields of the Early Treatment Diabetic Retinopathy Study grid and evaluated the qualitative and quantitative parameters on OCT sectional images. We investigated the relationship between these OCT parameters at baseline and the number of IVR injections during the 12-month follow-up.ResultsThree loading doses were administered to 10 eyes; four to seven annualized IVR injections were administered to 34 eyes. The number of eyes that received IVR injections decreased gradually until month 6 and was almost constant from months 7 to 11. No relationships were seen between the treatment frequency and baseline systemic factors and the ophthalmic examination findings. Univariate analyses showed that the number of IVR injections during the first year was associated with the mean retinal thickness in the individual subfields and the transverse length of the disrupted external limiting membrane (ELM) and ellipsoid zone of the photoreceptors. Multivariate analysis showed a significant association with the thickness in the inferior subfield alone. The treatment frequency during the 12-month follow-up was not correlated with improved visual acuity but was associated with the decrease in the central subfield thickness and disrupted ELM.ConclusionThe retinal thickness in the inferior subfield predicts the treatment frequency during the first year in eyes with DME treated with PRN IVR injections.

Highlights

Diabetic macular edema (DME), in which the blood-retinal barrier (BRB) is disrupted and neuroglial function deteriorates, often leads to visual impairment in patients with diabetes [1, 2]
A few clinical trials of intravitreal ranibizumab (IVR) injections for DME according to the pro re nata (PRN) regimen have reported significant reductions in the treatment frequency in the second year and thereafter [12, 13]
We investigated the association of baseline systemic and ocular characteristics with the number of PRN IVR injections administered during the first year (3 + PRN regimen) to treat DME

Summary

Introduction

Diabetic macular edema (DME), in which the blood-retinal barrier (BRB) is disrupted and neuroglial function deteriorates, often leads to visual impairment in patients with diabetes [1, 2]. Considering the half-lives of these drugs in the vitreous humor, three major regimens, i.e., fixed monthly or bimonthly, pro re nata (PRN), and treat-and-extend (TAE), can be applied to treat DME [7,8,9,10,11]. Anti-VEGF therapy improves the severity of and retards progression of diabetic retinopathy (DR) and the expansion of the nonperfused areas in the macula [14, 15]. These data suggested that anti-VEGF drugs have rapid and direct effects on the disrupted BRB and exert slow and indirect mechanisms in DME resolution

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