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

Abstract

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.

• Authors: Søren L Blindbaek, Tunde Peto, Jakob Grauslund
• Journal: Acta ophthalmologica (Acta Ophthalmol) Vol. 98 Issue 4 Pg. 347-352 (Jun 2020) ISSN: 1755-3768 [Electronic] England
• PMID: 31602811 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2019 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Chemical References

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

Topics

• Aged
• Angiogenesis Inhibitors (administration & dosage)
• Diabetic Retinopathy (diagnosis, 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