Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: Twelve-week results of an uncontrolled open-label clinical study

Stephan Michels, Philip J Rosenfeld, Carmen A. Puliafito, Erin N Marcus, Anna S. Venkatraman

Research output: Contribution to journalArticle

561 Citations (Scopus)

Abstract

Purpose: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). Design: Open-label, single-center, uncontrolled clinical study. Participants: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400). Methods: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. Main Outcome Measurements: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. Results: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 μm (P = 0.008) and 177 μm (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 μm (P = 0.028) and 92 μm (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. Conclusion: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.

Original languageEnglish
Pages (from-to)1035-1047
Number of pages13
JournalOphthalmology
Volume112
Issue number6
DOIs
StatePublished - Jun 1 2005

Fingerprint

Macular Degeneration
Visual Acuity
Choroidal Neovascularization
Optical Coherence Tomography
Blood Pressure
Therapeutics
Safety
Angiography
Indocyanine Green
San Francisco
Clinical Studies
Bevacizumab
Fluorescein Angiography
Antihypertensive Agents
Randomized Controlled Trials

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration : Twelve-week results of an uncontrolled open-label clinical study. / Michels, Stephan; Rosenfeld, Philip J; Puliafito, Carmen A.; Marcus, Erin N; Venkatraman, Anna S.

In: Ophthalmology, Vol. 112, No. 6, 01.06.2005, p. 1035-1047.

Research output: Contribution to journalArticle

@article{0573e10afd994a56948fbfc05cfc4804,
title = "Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: Twelve-week results of an uncontrolled open-label clinical study",
abstract = "Purpose: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). Design: Open-label, single-center, uncontrolled clinical study. Participants: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400). Methods: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. Main Outcome Measurements: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. Results: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 μm (P = 0.008) and 177 μm (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 μm (P = 0.028) and 92 μm (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. Conclusion: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.",
author = "Stephan Michels and Rosenfeld, {Philip J} and Puliafito, {Carmen A.} and Marcus, {Erin N} and Venkatraman, {Anna S.}",
year = "2005",
month = "6",
day = "1",
doi = "10.1016/j.ophtha.2005.02.007",
language = "English",
volume = "112",
pages = "1035--1047",
journal = "Ophthalmology",
issn = "0161-6420",
publisher = "Elsevier Inc.",
number = "6",

}

TY - JOUR

T1 - Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration

T2 - Twelve-week results of an uncontrolled open-label clinical study

AU - Michels, Stephan

AU - Rosenfeld, Philip J

AU - Puliafito, Carmen A.

AU - Marcus, Erin N

AU - Venkatraman, Anna S.

PY - 2005/6/1

Y1 - 2005/6/1

N2 - Purpose: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). Design: Open-label, single-center, uncontrolled clinical study. Participants: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400). Methods: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. Main Outcome Measurements: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. Results: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 μm (P = 0.008) and 177 μm (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 μm (P = 0.028) and 92 μm (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. Conclusion: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.

AB - Purpose: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). Design: Open-label, single-center, uncontrolled clinical study. Participants: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400). Methods: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. Main Outcome Measurements: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. Results: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 μm (P = 0.008) and 177 μm (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 μm (P = 0.028) and 92 μm (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. Conclusion: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.

UR - http://www.scopus.com/inward/record.url?scp=20144372969&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20144372969&partnerID=8YFLogxK

U2 - 10.1016/j.ophtha.2005.02.007

DO - 10.1016/j.ophtha.2005.02.007

M3 - Article

C2 - 15936441

AN - SCOPUS:20144372969

VL - 112

SP - 1035

EP - 1047

JO - Ophthalmology

JF - Ophthalmology

SN - 0161-6420

IS - 6

ER -