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Michael Singer, Sunil S. Patel, Harvey S. Uy, Ching-Chi Liu, Xiao-Yan Li, Scott M. Whitcup; Dexamethasone Intravitreal Implant (DEX Implant) Alone And As An Adjunct To Ranibizumab For The Treatment Of Choroidal Neovascularization (CNV) Secondary To Age-related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2011;52(14):3536.
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To report the efficacy of DEX implant alone and as an adjunct to ranibizumab for treatment of CNV secondary to AMD.
This open-label, 26-week, study enrolled 44 treatment-naive, subfoveal CNV patients with a total lesion size of ≤ 12 MPS DA, central retinal thickness (CRT) of ≥ 300 µm, and best-corrected visual acuity (BCVA) of ≥ 19 and ≤ 75 letters at baseline (day 1). Patients received DEX implant at baseline. Patients received ranibizumab at week 2 or 3 if BCVA was worsened by ≥ 5 letters or from week 4 on for wet AMD at the investigator’s discretion. Study endpoints were the mean change from baseline CRT at week 4 (primary), BCVA, angiographic macular leakage, and number of ranibizumab injections. For patients who received a ranibizumab injection before week 4, the endpoint values prior to the injection were carried forward for the primary efficacy analysis at week 4.
The mean change from baseline CRT at weeks 1, 4, 8, and 26 were, respectively, -40.3, -62.0, -124.6, and -133.7 µm (P < .001 for all compared to baseline). The percentage of patients with ≥ 15-letter improvement from baseline BCVA was 4.5% and 15.9%, respectively, at weeks 4 and 26, with a peak response of 20.5% at week 22. At baseline, all patients had macular leakage (n = 44). The percentage of patients with ≥10% decrease in macular leakage was 39.5% (17/43) and 74.4% (32/43), respectively, at weeks 4 and 26. Increases of ≥ 10% in macular leakage occurred in 2.3% (1/43) and 7.0% (3/43) of patients at weeks 4 and 26, respectively. The numbers of ranibizumab injections were 0, 1 to 3, and 4 to 6 in, respectively, 6.8%, 38.6%, and 54.5% of patients.
DEX implant alone or as an adjunct to ranibizumab for the treatment of CNV due to AMD significantly reduced CRT. DEX implant as an adjunct to ranibizumab improved BCVA and reduced macular leakage. DEX implant decreased the necessity for repeated ranibizumab injections.
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