TY - JOUR
T1 - Intravenous Bevacizumab Causes Regression of Choroidal Neovascularization Secondary to Diseases Other Than Age-related Macular Degeneration
AU - Nguyen, Quan Dong
AU - Shah, Syed Mahmood
AU - Hafiz, Gulnar
AU - Do, Diana Van
AU - Haller, Julia A.
AU - Pili, Roberto
AU - Zimmer-Galler, Ingrid E.
AU - Janjua, Kashif
AU - Symons, R. C.Andrew
AU - Campochiaro, Peter A.
N1 - Funding Information:
This study was supported by a Senior Scientist Award from Research to Prevent Blindness, New York, New York (Dr Campochiaro) and unrestricted grants (Dr and Mrs William Lake and Mr and Mrs Richard Heffner). The authors indicate no financial conflict of interest. Dr Nguyen is a recipient of a K23 Career Development Award (EY 13552) from the National Eye Institute. Involved in design and conduct of study (P.A.C., Q.D.N., G.H., D.V.D., J.A.H., R.P., I.E.Z.-G.); collection, management, analysis, and interpretation of the data (P.A.C., Q.D.N., G.H., S.M.S., K.J., A.S., I.E.Z.-G.); and preparation, review, or approval of the manuscript (P.A.C., Q.D.N., S.M.S., K.J., G.H., D.V.D., J.A.H., A.S., I.E.Z.-G., R.P.). The study was conducted in compliance with the Declaration of Helsinki, US Code 21 of Federal Regulations, the Harmonized Tripartite Guidelines for Good Clinical Practice (1996), and the institutional clinical trials review board of the Johns Hopkins University School of Medicine, and HIPAA. An Investigational New Drug (IND) application was filed with the Food and Drug Administration and an IND number was issued. The study is registered at clinicaltrials.gov ( NCT00407719 ).
PY - 2008/2
Y1 - 2008/2
N2 - Purpose: To investigate the safety, tolerability, and bioactivity of intravenous infusions of bevacizumab in patients with choroidal neovascularization (CNV) attributable to causes other than age-related macular degeneration. Design: Nonrandomized clinical trial. Methods: Ten patients with CNV received infusions of 5 mg/kg of bevacizumab. The primary efficacy outcome measure was change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters read at 4 meters) at 24 weeks and secondary measures were changes from baseline in excess foveal thickness (center subfield thickness), area of fluorescein leakage, and area of CNV. Results: Infusions were well tolerated and there were no ocular or systemic adverse events. At baseline, median VA was 25.5 letters read at 4 meters (20/80) and median foveal thickness was 346 μm. At the primary endpoint (24 weeks), median VA was 48.5 letters (20/32), representing four lines of improvement from baseline (P = .005), median foveal thickness was 248 μm representing a 72% reduction in excess foveal thickness (P = .007). Four of nine patients had complete elimination of fluorescein leakage, three had near complete elimination (reductions of 91%, 88%, and 87%), two had modest reductions, and one had no reduction. All patients except one showed a reduction in area of CNV with a median reduction of 43%. Conclusions: Despite the small number of patients studied, the marked improvement in VA accompanied by prominent reductions in foveal thickness, fluorescein leakage, and area of CNV suggest a beneficial effect. It may be worthwhile to consider further evaluation of systemic bevacizumab in young patients with CNV.
AB - Purpose: To investigate the safety, tolerability, and bioactivity of intravenous infusions of bevacizumab in patients with choroidal neovascularization (CNV) attributable to causes other than age-related macular degeneration. Design: Nonrandomized clinical trial. Methods: Ten patients with CNV received infusions of 5 mg/kg of bevacizumab. The primary efficacy outcome measure was change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters read at 4 meters) at 24 weeks and secondary measures were changes from baseline in excess foveal thickness (center subfield thickness), area of fluorescein leakage, and area of CNV. Results: Infusions were well tolerated and there were no ocular or systemic adverse events. At baseline, median VA was 25.5 letters read at 4 meters (20/80) and median foveal thickness was 346 μm. At the primary endpoint (24 weeks), median VA was 48.5 letters (20/32), representing four lines of improvement from baseline (P = .005), median foveal thickness was 248 μm representing a 72% reduction in excess foveal thickness (P = .007). Four of nine patients had complete elimination of fluorescein leakage, three had near complete elimination (reductions of 91%, 88%, and 87%), two had modest reductions, and one had no reduction. All patients except one showed a reduction in area of CNV with a median reduction of 43%. Conclusions: Despite the small number of patients studied, the marked improvement in VA accompanied by prominent reductions in foveal thickness, fluorescein leakage, and area of CNV suggest a beneficial effect. It may be worthwhile to consider further evaluation of systemic bevacizumab in young patients with CNV.
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U2 - 10.1016/j.ajo.2007.09.025
DO - 10.1016/j.ajo.2007.09.025
M3 - Article
C2 - 18054887
AN - SCOPUS:38349136548
SN - 0002-9394
VL - 145
SP - 257-266.e2
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
IS - 2
ER -