Ophthalmology
Volume 117, Issue 6 , Pages 1124-1133.e1, June 2010

Ranibizumab for Macular Edema following Central Retinal Vein Occlusion:

Six-Month Primary End Point Results of a Phase III Study

Portions of these data were presented at: the Retina Congress, September 2009, New York, NY; and the American Academy of Ophthalmology, November 2009, San Francisco, CA.

  • David M. Brown, MD, FACS

      Affiliations

    • Retina Consultants of Houston, The Methodist Hospital, Houston, Texas
    • Corresponding Author InformationCorrespondence: David M. Brown, MD, FACS, Retina Consultants of Houston, The Methodist Hospital, 6560 Fannin, Suite 750, Houston, TX 77030
    • ,
  • Peter A. Campochiaro, MD

      Affiliations

    • Johns Hopkins University School of Medicine, Baltimore, Maryland
    • ,
  • Rishi P. Singh, MD

      Affiliations

    • Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
    • ,
  • Zhengrong Li, PhD

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • Sarah Gray, PhD

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • Namrata Saroj, OD

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • Amy Chen Rundle, MS

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • Roman G. Rubio, MD

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • Wendy Yee Murahashi, MD

      Affiliations

    • Genentech, Inc., South San Francisco, California
    • ,
  • CRUISE Investigators

Received 24 December 2009; received in revised form 11 February 2010; accepted 17 February 2010. published online 09 April 2010.

Available online: April 9, 2010.

Purpose

To assess the efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after central retinal vein occlusion (CRVO).

Design

Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.

Participants

A total of 392 patients with macular edema after CRVO.

Methods

Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 or 0.5 mg of ranibizumab or sham injections.

Main Outcome Measures

The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).

Results

Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 12.7 (9.9–15.4) and 14.9 (12.6–17.2) in the 0.3 mg and 0.5 mg ranibizumab groups, respectively, and 0.8 (−2.0 to 3.6) in the sham group (P<0.0001 for each ranibizumab group vs. sham). The percentage of patients who gained ≥15 letters in BCVA at month 6 was 46.2% (0.3 mg) and 47.7% (0.5 mg) in the ranibizumab groups and 16.9% in the sham group (P<0.0001 for each ranibizumab group vs. sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg = 43.9%; 0.5 mg = 46.9%) had BCVA of ≥ 20/40 compared with sham patients (20.8%; P<0.0001 for each ranibizumab group vs. sham), and CFT had decreased by a mean of 434 μm (0.3 mg) and 452 μm (0.5 mg) in the ranibizumab groups and 168 μm in the sham group (P<0.0001 for each ranibizumab group vs. sham). The median percent reduction in excess foveal thickness at month 6 was 94.0% and 97.3% in the 0.3 mg and 0.5 mg groups, respectively, and 23.9% in the sham group. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with CRVO.

Conclusions

Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid improvement in 6-month visual acuity and macular edema following CRVO, with low rates of ocular and nonocular safety events.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

To access this article, please choose from the options below

Login to an existing account or Register a new account.

  • Purchase this article for 31.50 USD (You must login/register to purchase this article)

    Online access for 24 hours. The PDF version can be downloaded as your permanent record.

  • Subscribe to this title

    Get unlimited online access to this article and all other articles in this title 24/7 for one year.

  • Claim access now

    For current subscribers with Society Membership or Account Number.

  • Visit SciVerse ScienceDirect to see if you have access via your institution.
 

 Manuscript no. 2009-1757.

 *A list of study investigators (Appendix 1) is available at http://aaojournal.org.

 This article contains online-only material. The following should appear online only: CRUISE Investigators (see Appendix 1; available at http://aaojournal.org).

 Financial Disclosure(s): The author(s) have made the following disclosure(s): Genentech, Inc., South San Francisco, California, provided support for the study and participated in study design; conducting the study; and data collection, management, and interpretation. Genentech authors Saroj, Rundle, and Gray would like to report Equity Ownership in Roche.

PII: S0161-6420(10)00186-7

doi:10.1016/j.ophtha.2010.02.022

Ophthalmology
Volume 117, Issue 6 , Pages 1124-1133.e1, June 2010

Article Tools

* Image Usage & Resolution