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

AbstractPURPOSE:
To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO).
DESIGN:
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
PARTICIPANTS:
A total of 397 patients with macular edema following BRVO.
METHODS:
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg 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 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) 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 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 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 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO.
CONCLUSIONS:
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid, effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events.
AuthorsPeter A Campochiaro, Jeffrey S Heier, Leonard Feiner, Sarah Gray, Namrata Saroj, Amy Chen Rundle, Wendy Yee Murahashi, Roman G Rubio,
JournalOphthalmology (Ophthalmology) Vol. 117 Issue 6 Pg. 1102-1112.e1 (Jun 2010) ISSN: 1549-4713 [Electronic] United States
PMID20398941 (Publication Type: Clinical Trial, Phase III, Comparative Study, 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
  • Vascular Endothelial Growth Factor A
  • Ranibizumab
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors (administration & dosage)
  • Antibodies, Monoclonal (administration & dosage)
  • Antibodies, Monoclonal, Humanized
  • Double-Blind Method
  • Endpoint Determination
  • Female
  • Humans
  • Injections
  • Laser Coagulation
  • Macular Edema (drug therapy, etiology, physiopathology)
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab
  • Retinal Vein Occlusion (complications)
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A (antagonists & inhibitors)
  • Visual Acuity (physiology)
  • Vitreous Body

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