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S. Gupta, D. S. Boyer, D. Faber, S. S. Patel, C.-C. Liu, X.-Y. Li, S. M. Whitcup; Open-Label Phase 2 Study of Dexamethasone Intravitreal Implant for Treatment of Diabetic Macular Edema (DME) in Vitrectomized Patients: Interim Results. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4261.
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To evaluate the efficacy and safety of DEX Implant for treatment of diabetic macular edema (DME) in patients who have had prior pars plana vitrectomy (PPV).
This ongoing, prospective, multicenter, open-label, 26-week study enrolled patients with DME and prior PPV to receive a single injection of 0.7 mg DEX Implant into the vitrectomized eye. The primary efficacy measure was change in central retinal thickness by optical coherence tomography (OCT). Secondary endpoints included best corrected visual acuity (BCVA) and safety. This analysis includes data up to 13 weeks of treatment.
Of 56 enrolled patients, 55 received DEX Implant. Mean age was 62 years; mean duration of DME was 42 months. Improvement in DME was seen as early as 1 week after injection. Mean central retinal thickness by OCT had decreased from baseline (403 µm) by 119 µm (95% CI -150, -88; P < .001) at Week 1 and 113 µm (95% CI -147, -78; P < .001) at Week 13. BCVA also improved as early as 1 week after treatment and continued to improve out to Week 13. At Weeks 1 and 13, 18.5% and 30.9% of patients, respectively, achieved >/=10 letter gain, and no patient lost >/= 10 letters after 13 weeks. The most common adverse events in study eyes were conjunctival hemorrhage (24%), eye pain (13%), and conjunctival hyperemia (7%). Percentage of all patients with an intraocular pressure (IOP) increase >/=10mmHg from baseline peaked at Week 4 (7.5%) and decreased to 1.8% at Week 13. Only 1 (1.8%) patient had an IOP >/= 25mmHg over the course of the 13 weeks.
DEX Implant resulted in significant improvements in DME in vitrectomized eyes and appeared to be well tolerated.
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