Detailed analysis of retinal morphology in patients with diabetic macular edema (DME) randomized to ranibizumab or triamcinolone treatment

Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):49-58. doi: 10.1007/s00417-017-3828-1. Epub 2017 Oct 28.

Abstract

Purpose: Our purpose was to compare the impact in diabetic macula edema (DME) of two intravitreal drugs (0.5 mg ranibizumab vs. 8 mg triamcinolone) on changes in retinal morphology in spectral-domain optical coherence tomography (SD OCT) images, color fundus photography (CF) and fluorescein angiography (FA) images during a 1-year follow-up.

Methods: Post hoc analysis was conducted of morphologic characteristics in OCT, FA and CF images of eyes with a center involving DME that were included in a prospective double-masked randomized trial. Eligible patients were divided at random into two groups receiving either pro re nata treatment with 0.5 mg ranibizumab or 8 mg triamcinolone after a fixed loading dose. OCT and CF images were acquired at monthly visits and FA images every three months.

Results: Twenty-five eyes of 25 patients (ranibizumab: n = 10; triamcinolone: n = 15) were included in this study. Patients treated with ranibizumab showed better visual acuity results after 12 months than patients receiving triamcinolone (p = 0.015) although edema reduction was similar (p = 0.426) in both groups. The initial effect on macular edema shedding after a single ranibizumab injection could be amplified with the following two injections of the loading dose. After a single injection of triamcinolone the beneficial initial effect on the macula edema faded within 3 months. Subretinal fluid and INL cystoid spaces diminished early in the course of treatment while fluid accumulation in the ONL seemed to be more persistent in both treatment arms. In FA, the area of leakage diminished significantly in both treatment arms. After repeated injections the morphologic OCT and FA characteristics of the treatment arms converged.

Conclusions: Despite the higher dosage of triamcinolone, both therapies were safe and effective for treating diabetic macular edema. Fluid accumulation in the INL and subretinal space was more responsive to therapy than fluid accumulation in the ONL. Clinicaltrials.gov : NCT00682539.

Keywords: Diabetic macula edema; Diabetic retinopathy; Fluorescein angiography; OCT; Ranibizumab; Triamcinolone.

MeSH terms

  • Angiogenesis Inhibitors / administration & dosage
  • Diabetic Retinopathy / complications
  • Diabetic Retinopathy / diagnosis*
  • Diabetic Retinopathy / drug therapy
  • Double-Blind Method
  • Female
  • Fluorescein Angiography / methods
  • Follow-Up Studies
  • Fundus Oculi
  • Glucocorticoids / administration & dosage
  • Humans
  • Intravitreal Injections
  • Macula Lutea / pathology*
  • Macular Edema / diagnosis*
  • Macular Edema / drug therapy
  • Macular Edema / etiology
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab / administration & dosage*
  • Time Factors
  • Tomography, Optical Coherence / methods
  • Treatment Outcome
  • Triamcinolone Acetonide / administration & dosage*
  • Visual Acuity

Substances

  • Angiogenesis Inhibitors
  • Glucocorticoids
  • Triamcinolone Acetonide
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00682539