Efficacy of Ranibizumab in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion: Results From the Sham-Controlled ROCC Study

doi:10.1016/j.ajo.2010.03.028

American Journal of Ophthalmology

Volume 150, Issue 3, September 2010, Pages 310-314

https://doi.org/10.1016/j.ajo.2010.03.028 Get rights and content

Purpose

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.

Design

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 μm in the ranibizumab group and −86 ± 165 μm 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 μm with ranibizumab and −151 ± 205 μm 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.

Conclusion

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.

Section snippets

Methods

This was a 6-month, prospective, multicenter, randomized, double-masked, sham-controlled, monitored study conducted at 4 sites in Norway. The aim of the study was to evaluate the efficacy and safety of intravitreal ranibizumab in patients with macular edema secondary to CRVO.

Patients with macular edema secondary to CRVO in 1 eye, who were previously untreated for this disease, were included in the study. Inclusion criteria included symptom duration ≤6 months, age ≥50 years, and a best-corrected

Baseline Characteristics

Of the 32 patients enrolled, 29 (16 male, 13 female) completed the study. One patient from the ranibizumab group developed retinal artery thrombosis and was withdrawn from the study shortly after the first injection.¹⁹ Two patients from the sham group were also withdrawn from the study, 1 for planned surgery because of cholecystitis and the other following a diagnosis of AMD, a protocol violation.

At baseline, the mean age was 72 years (52–88 years) and the mean duration of CRVO was 78 days

Discussion

In this 6-month study, intravitreal ranibizumab injections resulted in significant anatomic and visual improvements in patients with macular edema secondary to CRVO. The need for repeated monthly injections of intravitreal anti-VEGF therapy to maintain efficacy was confirmed in this study. Although this is time consuming and requires additional healthcare resources, anti-VEGF therapy may provide a treatment option for a disease for which an effective permanent therapy has not been established.

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Original articleEfficacy of Ranibizumab in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion: Results From the Sham-Controlled ROCC Study

Purpose

Design

Methods

Results

Conclusion

Section snippets

Methods

Baseline Characteristics

Discussion

Am J Ophthalmol

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

Ophthalmology

Am J Ophthalmol

Ophthalmology

Am J Ophthalmol

Ophthalmology

Original article
Efficacy of Ranibizumab in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion: Results From the Sham-Controlled ROCC Study