title: Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study.
abstract: OBJECTIVE
  The ROCC study (randomized study comparing ranibizumab to sham in patients with macular edema secondary to central Retinal vein OCClusion [CRVO]) evaluated the short-term effect of intravitreal ranibizumab injections on best-corrected visual acuity (BCVA) and macular edema.
  
  
  METHODS
  Prospective, multicenter, randomized, double-masked, placebo-controlled trial.
  
  
  METHODS
  In this 6-month trial, 32 patients with macular edema secondary to CRVO were randomized to receive monthly intravitreal ranibizumab (0.5 mg/0.05 mL) or sham injections for 3 consecutive months. If macular edema persisted, patients received further monthly injections. Primary outcome measures were BCVA and central macular thickness (CMT) at 6 months.
  
  
  RESULTS
  Twenty-nine patients completed the study. After 3 months, BCVA improved by a mean +/- standard deviation (SD) of 16 +/- 14 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the ranibizumab group (n = 15), compared with a mean loss of 5 +/- 15 ETDRS letters in the sham group (n = 14; P = .001). The mean +/- SD change in CMT was -411 +/- 200 microm in the ranibizumab group and -86 +/- 165 microm with sham (P < .001). At 6 months, the mean +/- SD change in BCVA was 12 +/- 20 ETDRS letters in the ranibizumab group compared with -1 +/- 17 ETDRS letters in the sham group (P = .067). The mean +/- SD change in CMT was -304 +/- 194 microm with ranibizumab and -151 +/- 205 microm with sham (P = .05). Twelve patients (80%) in the ranibizumab group required more than 3 initial injections; mean +/- SD number of injections was 4.3 +/- 0.9 during the study.
  
  
  CONCLUSIONS
  Monthly ranibizumab significantly increased BCVA and decreased macular edema, compared with sham, in patients with CRVO. Repeated consecutive injections are necessary to maintain initial positive results.
authors.affiliation: Retinaklinikken Aleris, Fredrik Stangsgt 11-13, Oslo, Norway. Bettina.Kinge@kinge.no
authors.forename: Bettina
authors.initials: B
authors.lastname: Kinge
authors.forename: Per Bjørn
authors.initials: PB
authors.lastname: Stordahl
authors.forename: Vegard
authors.initials: V
authors.lastname: Forsaa
authors.forename: Kristian
authors.initials: K
authors.lastname: Fossen
authors.forename: Marta
authors.initials: M
authors.lastname: Haugstad
authors.forename: Ole Harald
authors.initials: OH
authors.lastname: Helgesen
authors.forename: Johan
authors.initials: J
authors.lastname: Seland
authors.forename: Ingar
authors.initials: I
authors.lastname: Stene-Johansen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D019233:Retreatment; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab