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Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study.

AbstractPURPOSE:
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 > or =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 > or = 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 microm (0.3 mg) and 452 microm (0.5 mg) in the ranibizumab groups and 168 microm 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.
AuthorsDavid M Brown, Peter A Campochiaro, Rishi P Singh, Zhengrong Li, Sarah Gray, Namrata Saroj, Amy Chen Rundle, Roman G Rubio, Wendy Yee Murahashi,
JournalOphthalmology (Ophthalmology) Vol. 117 Issue 6 Pg. 1124-1133.e1 (Jun 2010) ISSN: 1549-4713 [Electronic] United States
PMID20381871 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Ranibizumab
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors (administration & dosage, adverse effects)
  • Antibodies, Monoclonal (administration & dosage, adverse effects)
  • Antibodies, Monoclonal, Humanized
  • Double-Blind Method
  • Endpoint Determination
  • Female
  • Follow-Up Studies
  • Humans
  • Injections
  • Macular Edema (drug therapy, etiology, physiopathology)
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab
  • Retinal Vein Occlusion (complications, physiopathology)
  • Treatment Outcome
  • Visual Acuity (physiology)
  • Vitreous Body
  • Young Adult

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