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Victor H. Gonzalez, Diana V. Do, Husain Kazmi, Robert Vitti, Alyson J. Berliner, Georg Groetzbach, Rupert Sandbrink, Oliver Zeitz; Microperimetry assessment of retinal sensitivity in patients with diabetic macular edema - results from the Phase 2 Da Vinci study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2863.
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To evaluate the effect of intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye) compared to laser photocoagulation on retinal sensitivity in patients with diabetic macular edema (DME).
Patients (219) were randomized to 1 of 5 regimens: IAI 0.5 mg every 4 weeks; 2 mg every 4 weeks; 2 mg every 8 weeks following 3 initial monthly doses; 2 mg as needed following 3 initial monthly doses; or laser. The change in best-corrected visual acuity (BCVA) was measured at Week 24 (the primary endpoint) and at Week 52. Additional endpoints included the change in central retinal thickness (CRT) from baseline. Change in central retinal sensitivity was an exploratory endpoint measured by microperimetry in a subset of patients.
At Week 24, mean changes from baseline in BCVA in the combined IAI groups vs laser were 9.7 letters vs 2.5 letters (P<0.0001); at Week 52, changes were 11.5 letters vs -1.3 letters (P<0.0001). At Week 24, mean changes in CRT in the combined IAI groups vs laser were -155.2 µm vs -67.9 µm; at Week 52, changes were -190.0 µm vs -58.4 µm. IAI was generally well tolerated, with the most frequent ocular adverse events being conjunctival hemorrhage, eye pain, ocular hyperemia, and increased intraocular pressure. In patients who underwent microperimetry evaluation, the mean retinal sensitivity at Weeks 24 and 52 was significantly different from baseline for the combined IAI groups only (Table). At Week 52, patients in the combined IAI groups gained 2.03 decibels in retinal sensitivity vs a loss of 0.79 dB in the laser group.
Concomitant with improvement in visual acuity and central retinal thickness, statistically significant gains were seen in retinal sensitivity in the combined IAI groups versus the laser group in this small subset study of a large, randomized, prospective trial. The retinal sensitivity results, if confirmed by additional studies, are supportive of a beneficial effect of intravitreal aflibercept injection in the treatment of DME.
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