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Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point.
Ophthalmology 2013; 120(2):349-54O

Abstract

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.

Authors+Show Affiliations

Retina Consultants of Houston, The Methodist Hospital, Houston, Texas, USA. dmbmd@houstonretina.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23131717

Citation

Brown, David M., et al. "Super-dose anti-VEGF (SAVE) Trial: 2.0 Mg Intravitreal Ranibizumab for Recalcitrant Neovascular Macular Degeneration-primary End Point." Ophthalmology, vol. 120, no. 2, 2013, pp. 349-54.
Brown DM, Chen E, Mariani A, et al. Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point. Ophthalmology. 2013;120(2):349-54.
Brown, D. M., Chen, E., Mariani, A., & Major, J. C. (2013). Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point. Ophthalmology, 120(2), pp. 349-54. doi:10.1016/j.ophtha.2012.08.008.
Brown DM, et al. Super-dose anti-VEGF (SAVE) Trial: 2.0 Mg Intravitreal Ranibizumab for Recalcitrant Neovascular Macular Degeneration-primary End Point. Ophthalmology. 2013;120(2):349-54. PubMed PMID: 23131717.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point. AU - Brown,David M, AU - Chen,Eric, AU - Mariani,Angeline, AU - Major,James C,Jr AU - ,, Y1 - 2012/11/03/ PY - 2012/02/02/received PY - 2012/08/01/revised PY - 2012/08/03/accepted PY - 2012/11/8/entrez PY - 2012/11/8/pubmed PY - 2013/4/12/medline SP - 349 EP - 54 JF - Ophthalmology JO - Ophthalmology VL - 120 IS - 2 N2 - 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. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/23131717/Super_dose_anti_VEGF__SAVE__trial:_2_0_mg_intravitreal_ranibizumab_for_recalcitrant_neovascular_macular_degeneration_primary_end_point_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(12)00763-4 DB - PRIME DP - Unbound Medicine ER -