Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12-month randomized clinical trial

Acta Ophthalmol. 2020 Jun;98(4):347-352. doi: 10.1111/aos.14266. Epub 2019 Oct 10.


Purpose: To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment.

Methods: In 12-month randomized clinical trial, 48 eyes of 37 patients with centre-involved DME at Odense University Hospital were randomized 1:1 to receive three monthly injections of aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were examined monthly, and additional injections were given pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters compared with baseline). Outcome measures; (1) percentage of eyes that needed additional injections after laser in group A and B, (2) mean number of injections in group A and B, and (3) mean change in VA and CRT in group A and B.

Results: In the PRN phase, 60.5% of patients needed additional injections without differences between groups A and B (58.3 versus 63.2%, p > 0.99). The mean number of injections between baseline and month 12 was 4.4 (4.2 versus 4.6, p = 0.41). From baseline to month 12, VA improved by 8.4 ETDRS letters, and CRT was reduced by 97.4 μm (+9.4 versus +7.1 letters, p = 0.17, and -83.2 versus -115.4 μm, p = 0.21).

Conclusion: No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.

Keywords: anti-VEGF; diabetic macular oedema; focal/grid laser photocoagulation; randomized clinical trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / administration & dosage
  • Diabetic Retinopathy / diagnosis
  • Diabetic Retinopathy / therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Laser Coagulation / methods*
  • Macula Lutea / pathology
  • Macular Edema
  • Male
  • Middle Aged
  • Prospective Studies
  • Receptors, Vascular Endothelial Growth Factor / administration & dosage*
  • Recombinant Fusion Proteins / administration & dosage*
  • Time Factors
  • Tomography, Optical Coherence / methods
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity*


  • Angiogenesis Inhibitors
  • Recombinant Fusion Proteins
  • Vascular Endothelial Growth Factor A
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor