A randomized trial to compare the safety and efficacy of two ranibizumab dosing regimens in a Turkish cohort of patients with choroidal neovascularization secondary to AMD.

Abstract

PURPOSE:

To compare visual outcomes, number of visits and ranibizumab injections in patients treated with a Wait & Extend (W&E) or Treat & Observe (T&O) regimen.

METHODS:

This 12-month, randomized, multicentre, open-label study enrolled patients aged ≥ 50 years with choroidal neovascularization (CNV) secondary to AMD who had not received anti-VEGF agents. Patients received three monthly injections of ranibizumab before randomization (1:1): (i) T&O patients were examined monthly and retreated if needed, (ii) W&E patients had a follow-up visit 1 month later. If no lesions were active, the interval to the next visit was extended by 2 weeks to a maximum of 8 weeks. Active lesions were re-treated and the follow-up schedule restarted. Primary end-point was change in BCVA at Month 12.

RESULTS:

Of the 104 screened patients, 99 were eligible and received ≥ 1 ranibizumab injection; 93 were randomized (T&O: 45, W&E: 48). The median (interquartile range [IQR]) change in BCVA (logMAR) from baseline at Month 12 was similar between groups (T&O: -0.12 [0.38]; W&E: -0.18 [0.32], p = 0.267). Median (IQR) number of visits at study end (including screening, baseline and control visit after 1st injection) was 15.0 (1.0) for T&O, and 12.0 (2.0) for W&E (p < 0.001). Injection numbers were similar between groups (median [IQR]: 6.0 [3.0] and 5.0 [4.0], respectively, p = 0.215). Adverse events were similar between groups.

CONCLUSION:

W&E regimen resulted in a similar efficacy and safety profile to the labelled T&O regimen in patients with CNV secondary to AMD, and may help reduce the burden of follow-up visits.

• Authors: Bora M Eldem, Gulipek Muftuoglu, Seyhan Topbaş, Mehmet Çakir, Sibel Kadayifcilar, Emin Özmert, Halil Bahçecioğlu, Feride Sahin, Serhan Sevgi, SALUTE study group
• Journal: Acta ophthalmologica (Acta Ophthalmol) Vol. 93 Issue 6 Pg. e458-64 (Sep 2015) ISSN: 1755-3768 [Electronic] England
• PMID: 25160859 (Publication Type: Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Chemical References

• Angiogenesis Inhibitors
• VEGFA protein, human
• Vascular Endothelial Growth Factor A
• Ranibizumab

Topics

• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (administration & dosage, adverse effects)
• Choroidal Neovascularization (diagnosis, drug therapy, etiology, physiopathology)
• Female
• Fluorescein Angiography
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Observation
• Ranibizumab (administration & dosage, adverse effects)
• Tomography, Optical Coherence
• Turkey
• Vascular Endothelial Growth Factor A (antagonists & inhibitors)
• Visual Acuity (physiology)
• Watchful Waiting
• Wet Macular Degeneration (complications, diagnosis, drug therapy, physiopathology)