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Repeated intravitreal injections of antivascular endothelial growth factors and risk of intraocular pressure medication use.

ABSTRACT: PURPOSE:To determine the risk of initiating ocular hypertension and glaucoma treatment with repeated injections of antivascular endothelial growth factors (anti-VEGF). METHODS:A unique, retrospective cohort study was performed using a large national US medical claim database. The study population included patients who had 1 or more injections of an anti-VEGF agent. Exclusion occurred for any previous glaucoma, glaucoma suspect, glaucoma-related procedure, an ocular steroid injection, or not seeing an eye care provider at least once in each year of follow-up. Cohorts were divided into quartiles based on the number of injections performed over the follow-up period. Patients were observed for 2 and 3 years. The main outcome measure was defined as any new prescription for an ocular antihypertensive medication with a concurrent diagnosis of glaucoma, glaucoma suspect, or ocular hypertension. Multivariate logistic regression determined the odds of initiating glaucoma treatment in each injection quartile while controlling for numerous covariates. Sensitivity analysis assessed outcomes that included new medication only as well as a new medication plus diagnosis of glaucoma. RESULTS:In total, 17,113 and 9992 patients met 2- and 3-year observation end points, respectively. The multivariate odds ratio for initiating glaucoma treatment at 2 years was higher in the highest quartile (OR 1.96, 95% CI 1.39-2.76, p?

SUBMITTER: Cui QN

PROVIDER: S-EPMC6698200 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Repeated intravitreal injections of antivascular endothelial growth factors and risk of intraocular pressure medication use.

Cui Qi N QN Gray Iga N IN Yu Yinxi Y VanderBeek Brian L BL

Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie 20190531 9

<h4>Purpose</h4>To determine the risk of initiating ocular hypertension and glaucoma treatment with repeated injections of antivascular endothelial growth factors (anti-VEGF).<h4>Methods</h4>A unique, retrospective cohort study was performed using a large national US medical claim database. The study population included patients who had 1 or more injections of an anti-VEGF agent. Exclusion occurred for any previous glaucoma, glaucoma suspect, glaucoma-related procedure, an ocular steroid injecti ...[more]

PMID: 31152311

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Project description:PurposeRoutine use of face masks for patients and physicians during intravitreal anti-vascular endothelial growth factor (VEGF) injections has increased with the emergence of the coronavirus disease 2019 pandemic. This study evaluates the impact of universal face mask use on rates and outcomes of post-injection endophthalmitis (PIE).DesignRetrospective, multicenter, comparative cohort study.ParticipantsEyes receiving intravitreal anti-VEGF injections from October 1, 2019, to July 31, 2020, at 12 centers.MethodsCases were divided into a "no face mask" group if no face masks were worn by the physician or patient during intravitreal injections or a "universal face mask" group if face masks were worn by the physician, ancillary staff, and patient during intravitreal injections.Main outcome measuresRate of endophthalmitis, microbial spectrum, and visual acuity (VA).ResultsOf 505 968 intravitreal injections administered in 110 547 eyes, 85 of 294 514 (0.0289%; 1 in 3464 injections) cases of presumed endophthalmitis occurred in the "no face mask" group, and 45 of 211 454 (0.0213%; 1 in 4699) cases occurred in the "universal face mask" group (odds ratio [OR], 0.74; 95% confidence interval [CI], 0.51-1.18; P = 0.097). In the "no face mask" group, there were 27 cases (0.0092%; 1 in 10 908 injections) of culture-positive endophthalmitis compared with 9 cases (0.004%; 1 in 23 494) in the "universal face mask" group (OR, 0.46; 95% CI, 0.22-0.99; P = 0.041). Three cases of oral flora-associated endophthalmitis occurred in the "no face mask" group (0.001%; 1 in 98 171 injections) compared with 1 (0.0005%; 1 in 211 454) in the "universal face mask" group (P = 0.645). Patients presented a mean (range) 4.9 (1-30) days after the causative injection, and mean logarithm of the minimum angle of resolution (logMAR) VA at endophthalmitis presentation was 2.04 (~20/2200) for "no face mask" group compared with 1.65 (~20/900) for the "universal face mask" group (P = 0.022), although no difference was observed 3 months after treatment (P = 0.764).ConclusionsIn a large, multicenter, retrospective study, physician and patient face mask use during intravitreal anti-VEGF injections did not alter the risk of presumed acute-onset bacterial endophthalmitis, but there was a reduced rate of culture-positive endophthalmitis. Three months after presentation, there was no difference in VA between the groups.

Project description:ImportanceDespite the unquestionable effectiveness of anti-vascular endothelial growth factor therapy (VEGF), there is ongoing controversy about potential systemic adverse effects. Besides the direct adverse effects of anti-VEGF agents, other factors associated with the injection itself, such as perioperative blood pressure fluctuations, may contribute to adverse events.ObjectiveTo determine blood pressure fluctuations during intravitreal injections.Design, setting, and participantsProspective observational study at a tertiary referral center (Department of Ophthalmology, University Hospital Bern, Bern, Switzerland). Consecutive patients scheduled for intravitreal injections were recruited. Data were analyzed between October 2017 and January 2018.Main outcomes and measuresSystolic and diastolic blood pressure, pulse rate, and oxygen saturation were recorded before, during, and after the intravitreal injection. An anxiety questionnaire was completed by all participants. Multivariate regression analysis was used to investigate potential factors associated with blood pressure rise during injections.ResultsTwo hundred one patients (92 women and 109 men) were included in this study, with a mean age of 68 years (range, 18-93 years). Mean (SD) systolic blood pressure increased from a baseline of 150 (20) mm Hg to 162 (24) mm Hg following the preparation procedure to 168 (24) mm Hg during the injection (P < .001). Mean (SD) diastolic blood pressure increased from 78 (14) mm Hg to 83 (37) mm Hg to 83 (16) mm Hg, respectively (P = .009). Mean (SD) pulse frequency increased from 76 (13) bpm to 80 (13) bpm (P = .005). In total, 23 patients (11%) had a systolic blood pressure greater than 200 mm Hg. This subgroup of patients had a mean (SD) perioperative systolic blood pressure increase from 182 (19) mm Hg to 214 (12) mm Hg, resulting in an increase of 32 (20) mm Hg (P < .001). Age and anxiety were to be next associated with systolic blood pressure rise.Conclusions and relevanceThe intravitreal injection process is associated with a transient increase in blood pressure. Most of the increase occurs following the preparation before the injection itself. This may constitute a risk factor for cardiovascular or cerebrovascular complications during treatment and could be of particular relevance in patients at high risk for such events and those receiving frequent injections. Future work may be needed to determine whether, in patients at risk for cardiovascular or cerebrovascular events, perioperative blood pressure monitoring or antihypertensive therapy needs to be considered.

Project description:BackgroundIntravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are the standard of care for diabetic macular edema (DME), a common complication of diabetes. This study aimed to identify factors influencing DME intravitreal anti-VEGF treatment outcomes in real-world practice.MethodsThis was a multi-center retrospective observational study using medical chart review of participants receiving anti-VEGF injections for DME (N = 248). Demographic and clinical variables were assessed for association with best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes using regression models.ResultsThere was a significant improvement in BCVA (p < 0.001) and CMT (p < 0.001) after 12 months of treatment, although 21% of participants had decreased BCVA, and 41% had a < 10% CMT reduction at 12 months. Higher baseline BCVA (p = 0.022, OR=-0.024, 95% CI=-0.046,-0.004) and longer duration of diabetic retinopathy (p = 0.048, OR=-0.064, 95% CI=-0.129,-0.001) were negative predictors for BCVA response, whereas Aflibercept treatment (p = 0.017, OR = 1.107, 95% CI = 0.220,2.051) compared with other drugs and a positive "early functional response" (p < 0.001, OR=-1.393, 95% CI=-1.946,-0.857) were positive predictors. A higher baseline CMT (p < 0.001, OR = 0.019, 95% CI = 0.012,0.0261) and an "early anatomical response", (p < 0.001, OR=-1.677, 95% CI=-2.456, -0.943) were predictors for greater reduction in CMT. Overall, the variables could predict only 23% of BCVA and 52% of CMT response.ConclusionsThe study shows a significant proportion of DME patients do not respond to anti-VEGF therapy and identifies several clinical predictors for treatment outcomes.Trial registrationThe study was approved through the Human Research Ethics Committee, University of Tasmania (approval number H0012902), and the Southern Adelaide Clinical Human Research Ethics Committee (approval number 86 - 067).

Project description:For the management of retinal disease, the use of intravitreous injections of anti-vascular endothelial growth factor has increased. Recent reports have suggested that this therapy may cause sustained elevation of intraocular pressure (IOP) and may potentially increase the risk of glaucoma for patients with retinal disease.To assess the risk of sustained IOP elevation or the need for IOP-lowering treatments for eyes with diabetic macular edema following repeated intravitreous injections of ranibizumab.An exploratory analysis was conducted within a Diabetic Retinopathy Clinical Research Network randomized clinical trial. Study enrollment dates were from March 20, 2007, to December 17, 2008. Of 582 eyes (of 486 participants) with center-involved diabetic macular edema and no preexisting open-angle glaucoma, 260 were randomly assigned to receive a sham injection plus focal/grid laser treatment, and 322 were randomly assigned to receive ranibizumab plus deferred or prompt focal/grid laser treatment.The cumulative probability of sustained IOP elevation, defined as IOP of at least 22 mm Hg and an increase of at least 6 mm Hg from baseline at 2 consecutive visits, or the initiation or augmentation of ocular hypotensive therapy, through 3 years of follow-up.The mean (SD) baseline IOP in both treatment groups was 16 (3) mm Hg (range, 5-24 mm Hg). The cumulative probability of sustained IOP elevation or of initiation or augmentation of ocular hypotensive therapy by 3 years, after repeated ranibizumab injections, was 9.5% for the participants who received ranibizumab plus prompt or deferred focal/grid laser treatment vs 3.4% for the participants who received a sham injection plus focal/grid laser treatment (difference, 6.1% [99% CI, -0.2% to 12.3%]; hazard ratio, 2.9 [99% CI, 1.0-7.9]; P =?.01). The distribution of IOP and the change in IOP from baseline at each visit through 3 years were similar in each group.In eyes with center-involved diabetic macular edema and no prior open-angle glaucoma, repeated intravitreous injections of ranibizumab may increase the risk of sustained IOP elevation or the need for ocular hypotensive treatment. Clinicians should be aware of this risk and should consider this information when following up with patients who have received intravitreous injections of anti-vascular endothelial growth factor for the treatment of diabetic macular edema.

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Repeated intravitreal injections of antivascular endothelial growth factors and risk of intraocular pressure medication use.

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Repeated intravitreal injections of antivascular endothelial growth factors and risk of intraocular pressure medication use.

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