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Treatment of Intractable Diabetic Macular Edema with Pegaptanib Versus Bevacizumab, Both in Combination with Dexamethasone Diana M

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Treatment of Intractable Diabetic Macular Edema with Pegaptanib Versus Bevacizumab, Both in Combination with Dexamethasone Diana M Kansas Journal of Medicine 2012 Intractable Diabetic Macular Edema Treatment of Intractable Diabetic Macular Edema with Pegaptanib Versus Bevacizumab, Both in Combination with Dexamethasone Diana M. Leitner, M.D.1, David M. Chacko, M.D., Ph.D.1,2, Philip Twumasi-Ankrah, Ph.D.3, Elizabeth Ablah, Ph.D., M.P.H.3 1University of Kansas School of Medicine-Wichita Department of Internal Medicine 2Grene Vision Group, Wichita, KS 3 University of Kansas School of Medicine-Wichita Department of Preventive Medicine and Public Health Abstract Background . Diabetic macular edema is a significant cause of vision loss, and some patients do not respond optimally to existing treatments. This study compared the response of intractable diabetic macular edema to intravitreal injection of two anti-VEGF drugs, bevacizumab and pegaptanib, both in combination with dexamethasone. Methods . A retrospective chart review was conducted to examine patients from an ophthalmology practice in one year with diabetic macular edema (DME), recurrent or persistent, after focal laser or intravitreal bevacizumab. Patients received bevacizumab/dexamethasone or pegaptanib/dexamethasone. Outcome measures were improvement in best corrected visual activity (converted to LogMAR) and central macular thickness (CRT). Data on adverse effects also were collected. Results. The bevacizumab/dexamethasone group included 25 eyes which had pre-treatment LogMAR = 0.69 ± 0.49 (mean ± SD) and CRT = 419 ± 131. Post-treatment LogMAR was 0.70 ± 0.48 and CRT = 377 ± 107. The pegaptanib/dexamethasone group included 14 eyes; pre- treatment LogMAR = 0.80 ± 0.55 and CRT = 520 ± 108. Post-treatment LogMAR was 0.77 ± 0.49 and CRT = 46 4 ± 106. Neither treatment had a significant effect on visual acuity. Both groups experienced a significant decrease in CRT over time (p = 0.006). The pegaptanib/ dexamethasone group had higher CRT at all times (p = 0.020), but the trend in CRT decrease was not different between the two groups. Intraocular pressure increased in both groups (p = 0.038). No other adverse effects were reported. Conclusions . Neither bevacizumab/dexamethasone or pegaptanib/dexamethasone significantly improved visual acuity in intractable DME, but both decreased central macular thickness. Differences in outcome measures between the two treatment groups were not significant. The only adverse effect seen was a small increase in intraocular pressure. KS J Med 2012; 5(3):83-93. Introduction Diabetic retinopathy occurs in into the retina. 4-5 The resulting edema causes approximately 29% of persons with diabetes damage which can impair visual acuity and mellitus and is severe enough to threaten may result in blindness. 6-7 The prevalence of vision among 4.4%. 1-3 Diabetic macular DME in diabetic patients varies from 0.9% edema (DME) is a type of retinopathy to 29%. 8-10 Diabetic retinopathy is the resulting from microvascular damage to leading cause of new onset blindness among retinal capillaries, causing breakdown of the Americans 20 to 74 years old 1 and accounts blood-retinal barrier and allowing leakage for 4.8% of blindness worldwide.11 83 Kansas Journal of Medicine 2012 Intractable Diabetic Macular Edema Treatment for diabetic macular edema is Additionally, no published studies have complex, controversial, and changing. Laser examined the efficacy of combination photocoagulation with a focal/grid laser can therapy with dexamethasone and anti-VEGF decrease vision loss from DME,12-14 drugs. This study was designed to compare however, a number of patients fail to the efficacy of combined intravitreal respond optimally to laser treatment. treatments of pegaptanib/dexamethasone Inflammatory processes may be an versus bevacizumab/dexamethasone for important component of retinal damage in intractable DME. DME, 15 which has led to investigation of intravitreal corticosteroids as a possible Methods treatment. 16-18 Studies suggest intravitreal Participants. A retrospective chart dexamethasone improves visual acuity and review was conducted to examine patients central macular thickness. 19,20 Adverse with DME in an ophthalmology practice effects of intravitreal steroids include who were treated during the 2010 calendar glaucoma and cataract formation. 21-22 year with intravitreal bevacizumab/dexa- Vascular endothelial growth factor methasone or pegaptanib/dexamethasone. (VEGF) is another proposed culprit for Patients who were diagnosed with severe damage in DME, possibly via increased DME refractory to other treatments vascular permeability and action as a pro- including focal laser therapy or intravitreal inflammatory mediator. 23,24 bevacizumab monotherapy had been offered Bevacizumab (Avastin ®) is a combined treatment with intravitreal recombinant humanized antibody that dexamethasone and an anti-VEGF agent. targets many VEGF isoforms. 25 Intravitreal Instrument. Inclusion criteria included a bevacizumab is used off-label for DME. 26-31 diagnosis of diabetic macular edema and an Adverse effects of intravitreal bevacizumab intravitreal injection of bevacizumab/dexa- include anterior chamber reactions from methasone or pegaptanib/dexamethasone. injection, increased intraocular pressure, Patients who were lost to follow-up within endophthalmitis, and rare systemic five weeks of treatment were excluded. All effects.27,32-34 eyes which met the inclusion/exclusion Pegaptanib (Macugen ®) is a pegylated criteria were included in the analysis. The aptamer that binds and neutralizes primarily following data were collected from patient the 165-isomer of VEGF. It is approved for charts: best corrected visual acuity, central intravitreal use and is used off-label for macular thickness measured by ocular DME.35-37 Possible adverse effects of coherence tomography (Cirrus HD OCT, intravitreal pegaptanib treatment include Carl Zeiss Meditec, Jena, Germany), and endophthalmitis, retinal detachment, and intraocular pressure (Tono-Pen, Reichert traumatic cataracts. 38-40 Research has not Technologies, Depew, New York, USA). determined the ideal treatment algorithm for Data also were collected on patient diabetic macular edema and the role of anti- demographics, duration of diabetes, and VEGF therapies. 41 potential adverse effects of the treatment. No studies have been published Method of Injections. After informed comparing the efficacy of bevacizumab and consent, patients were anesthetized with one pegaptanib. These two anti-VEGF agents drop of viscous lidocaine and two sets of have slightly different structures and proparacaine ophthalmic drops two minutes mechanisms of action and bevacizumab is apart. One minute after the final anesthetic significantly less expensive than pegaptanib. drop, subconjunctival injection of 2% 84 Kansas Journal of Medicine 2012 Intractable Diabetic Macular Edema lidocaine with epinephrine was performed. and extended observation values measured The eye was prepared with topical 10% at the last visit of the year (an average of 4.5 Betadine ®, with application repeated after months after initial treatment). Changes in five minutes. Intravitreal injection was clinical endpoints were assessed as the performed with one of the following agents: difference between the baseline measure- 1.25 mg bevacizumab, 0.03 mg pegaptanib, ment and the immediate post-treatment or 0.4 mg dexamethasone. Patients were measurement. Baseline values for each instructed to use polymixin B/trimethoprim variable were defined as the last measure- (Polytrim ®) ophthalmic drops four times per ment collected prior to intravitreal drug day for three days before injections and one administration. Repeated measures multi- week following injections. Patients treated variate analysis of variance (rMANOVA) with combined therapy received dexa- was used to determine statistical signi- methasone and an anti-VEGF agent via the ficance after Mauchly’s test of sphericity same procedure one to six weeks apart. determined the appropriate statistical Some patients received additional intra- method. 44-46 A p-value less than 0.05 was vitreal treatments after the conclusion of considered significant. data gathering, depending on response to This project was approved by the Human treatment. Subjects Committee at the University of The clinical endpoints of this study were Kansas School of Medicine-Wichita. best corrected visual acuity (BCVA) and central macular thickness (CRT). Visual Results acuity was measured on the Snellen chart In the 2010 calendar year, 25 eyes were with the patient’s current prescription and treated with combined bevacizumab/ with a pinhole. When visual acuity dexamethasone administered within a 6- improved significantly with the pinhole, this week period (Table 1). There was large measurement was used as BCVA to variability in this sample; the average pre- decrease refractive error as a source of treatment LogMAR was 0.69 ± 0.49 (mean reduced visual acuity. BCVA was converted ± standard deviation) corresponding to an to the logarithm of the minimum angle of average visual acuity of 20/98, and average resolution (LogMAR) for analysis. 42 Central CRT was 419 ± 131 nm before treatment macular thickness (microns) was measured (Table 2). Initial post-treatment visual acuity by ocular coherence tomography; this improved in eight eyes (32%); decreased measurement has been shown to correlate visual acuity was seen in seven eyes (28%), with visual acuity and severity of and 10 eyes (40%) experienced no change in retinopathy. 43 Change in intraocular pressure visual acuity. (IOP, measured in mmHg) from baseline
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