Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point

David M Brown, Eric Chen, Angeline Mariani, James C Major
Ophthalmology 2013, 120 (2): 349-54

PURPOSE: To determine whether a higher dose of intravitreal ranibizumab could improve the anatomy and best-corrected visual acuity (BCVA) in eyes with neovascular age-related macular degeneration (AMD) with persistent disease activity despite monthly intravitreal anti-vascular endothelial growth factor (VEGF) injections.

DESIGN: Phase I to II multicenter, open-label, controlled clinical trial.

PARTICIPANTS: Eighty-seven patients with recalcitrant neovascular AMD, defined as having leakage on fundus fluorescein angiography or spectral domain optical coherence tomography (SD-OCT) despite monthly anti-VEGF injections.

METHODS: Patients were treated with 2.0-mg ranibizumab injections monthly for 3 doses and monitored with Early Treatment Diabetic Retinopathy Study (ETDRS) 4-m refractions, clinical examinations, and SD-OCT.

MAIN OUTCOME MEASURES: The mean change in baseline visual acuity (VA), the percentage of patients who experienced a loss or gain of 15 or more letters in ETDRS BCVA, the mean change in central retinal thickness, and the incidence of adverse events.

RESULTS: Eighty-seven patients with an average of 24 injections before enrollment and a mean of 10.4 injections in the preceding 12 months had a mean refracted VA of 69.2 ETDRS letters (20/41 Snellen) and a mean central subfield of 422 μm at baseline. Mean VA gain over baseline was +2.5 letters at day 7 (n = 82), +3.7 letters at month 1 (n = 87), +3.9 letters at month 2 (n = 87), and +3.3 letters at month 3 (20/36 Snellen; P = 0.001; n = 86). Anatomic outcomes showed a mean optical coherence tomography central subfield thickness improvement from baseline of -48.4 μm at day 7 (n = 84), -37.5 μm at month 1 (n = 87), -42.4 μm at month 2 (n = 85), and -33.1 μm at month 3 (P = 0.01; n = 86).

CONCLUSIONS: Intravitreal injections of 2.0 mg ranibizumab led to statistically significant VA gains and anatomic improvement in patients with persistent intraretinal, subretinal, or subretinal pigment epithelial fluid during a previous regimen of chronic monthly 0.5-mg ranibizumab injections.


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Available on the App Store

Available on the Play Store
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"