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Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study.
- Source :
-
Ophthalmology [Ophthalmology] 2010 Jun; Vol. 117 (6), pp. 1124-1133.e1. Date of Electronic Publication: 2010 Apr 09. - Publication Year :
- 2010
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Abstract
- 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).<br />Design: Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.<br />Participants: A total of 392 patients with macular edema after CRVO.<br />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.<br />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).<br />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.<br />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.<br /> (Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Angiogenesis Inhibitors adverse effects
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Double-Blind Method
Endpoint Determination
Female
Follow-Up Studies
Humans
Injections
Macular Edema etiology
Macular Edema physiopathology
Male
Middle Aged
Prospective Studies
Ranibizumab
Retinal Vein Occlusion physiopathology
Treatment Outcome
Visual Acuity physiology
Vitreous Body
Young Adult
Angiogenesis Inhibitors administration & dosage
Antibodies, Monoclonal administration & dosage
Macular Edema drug therapy
Retinal Vein Occlusion complications
Subjects
Details
- Language :
- English
- ISSN :
- 1549-4713
- Volume :
- 117
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Ophthalmology
- Publication Type :
- Academic Journal
- Accession number :
- 20381871
- Full Text :
- https://doi.org/10.1016/j.ophtha.2010.02.022