title: 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: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.affiliation: Faculty of Medicine, Hacettepe University, Ankara, Turkey.
authors.forename: Bora M
authors.initials: BM
authors.lastname: Eldem
authors.affiliation: Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey.
authors.forename: Gulipek
authors.initials: G
authors.lastname: Muftuoglu
authors.affiliation: Faculty of Medicine, Osmangazi University, Eskisehir, Turkey.
authors.forename: Seyhan
authors.initials: S
authors.lastname: Topbaş
authors.affiliation: Prof. Dr. N. Reşat Belger Beyoglu Eye Diseases Training Hospital, Istanbul, Turkey.
authors.forename: Mehmet
authors.initials: M
authors.lastname: Çakir
authors.affiliation: Faculty of Medicine, Hacettepe University, Ankara, Turkey.
authors.forename: Sibel
authors.initials: S
authors.lastname: Kadayifcilar
authors.affiliation: Faculty of Medicine, Ankara University, Ankara, Turkey.
authors.forename: Emin
authors.initials: E
authors.lastname: Özmert
authors.affiliation: Istanbul Florence Nightingale Hospital, Istanbul, Turkey.
authors.forename: Halil
authors.initials: H
authors.lastname: Bahçecioğlu
authors.affiliation: Novartis, Istanbul, Turkey.
authors.forename: Feride
authors.initials: F
authors.lastname: Sahin
authors.affiliation: Novartis, Istanbul, Turkey.
authors.forename: Serhan
authors.initials: S
authors.lastname: Sevgi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D019370:Observation; D000069579:Ranibizumab / Q000008:administration & dosage* / Q000009:adverse effects; D041623:Tomography, Optical Coherence; D014421:Turkey; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology; D057832:Watchful Waiting; D057135:Wet Macular Degeneration / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: Treat & Observe regimen; Wait & Extend regimen; age-related macular degeneration; ranibizumab