Dataset Information

The effect of intravitreal bevacizumab (Avastin) on ocular pulse amplitude in neovascular age-related macular degeneration.

ABSTRACT: To evaluate the effect of intravitreal (IVT) bevacizumab in neovascular age-related macular degeneration (AMD) on global choroidal hemodynamics, as measured by ocular pulse amplitude (OPA).This was a two-center prospective study (Sheba Medical Center, Israel, and University Hospitals Leuven, Belgium). AMD patients who required IVT bevacizumab (1.25 mg/0.05 mL; first or repeated) were examined three times: at days 0 (prior to injection), 7 (±3), and 28 (±7) postinjection. At each visit, OPAs of both eyes were measured using the Pascal dynamic contour tonometer (DCT). A paired t-test between preoperative and postoperative OPA was conducted. Pearson correlation was used to evaluate the influence of various measured parameters on DCT-OPA.A total of 38 neovascular AMD patients were recruited, and 30 patients were included in the final analysis (18 females and 12 males; age 78.8 ± 5.82 years [mean ± standard deviation]). A good correlation was found throughout the study between the DCT-intraocular pressure (IOP) and Goldmann IOP and between DCT-IOP and DCT-OPA. No change in OPA of bevacizumab-treated eyes was found between the visits (2.24 ± 0.73, 2.2 ± 0.86, and 2.23 ± 0.73 mm Hg at visits 1, 2, and 3, respectively; paired t-test: P = 0.77 between visits 1 and 2, P = 0.98 between visits 1 and 3). No correlations were found between DCT-OPA and age, heart rate, systemic blood pressure, axial length, keratometry readings, and central corneal thickness.OPA, an indirect measure of global choroidal hemodynamics, remains unchanged following IVT off-label bevacizumab. This finding adds to the growing evidence regarding the safety profile of bevacizumab in AMD treatment.

SUBMITTER: Rechtman E

PROVIDER: S-EPMC3048056 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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The effect of intravitreal bevacizumab (Avastin) on ocular pulse amplitude in neovascular age-related macular degeneration.

Rechtman Ehud E Stalmans Ingeborg I Glovinsky Joseph J Breusegem Christophe C Moisseiev Joseph J Van Calster Joachim J Harris Alon A

Clinical ophthalmology (Auckland, N.Z.) 20110106

<h4>Purpose</h4>To evaluate the effect of intravitreal (IVT) bevacizumab in neovascular age-related macular degeneration (AMD) on global choroidal hemodynamics, as measured by ocular pulse amplitude (OPA).<h4>Methods</h4>This was a two-center prospective study (Sheba Medical Center, Israel, and University Hospitals Leuven, Belgium). AMD patients who required IVT bevacizumab (1.25 mg/0.05 mL; first or repeated) were examined three times: at days 0 (prior to injection), 7 (±3), and 28 (±7) postinj ...[more]

PMID: 21386919

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Project description:BackgroundClinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.MethodsIn a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart.ResultsBevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.ConclusionsAt 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).

Project description:ObjectiveTo describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment.DesignMulticenter, randomized clinical trial.ParticipantsPatients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial.InterventionsAt enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment.Main outcome measuresMean change in visual acuity.ResultsAmong patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P = 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF).ConclusionsRanibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF.

Dataset Information

The effect of intravitreal bevacizumab (Avastin) on ocular pulse amplitude in neovascular age-related macular degeneration.

Publications

The effect of intravitreal bevacizumab (Avastin) on ocular pulse amplitude in neovascular age-related macular degeneration.

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