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Michael J. Tolentino, Diana Do; One-year Results Of The Da Vinci Study Of VEGF Trap-Eye In DME. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6646.
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VEGF Trap-Eye is an intravitreally administered fusion protein that is designed to bind the pro-angiogenic factors VEGF-A and placental growth factor. This study compared different doses and dosing regimens of VEGF Trap-Eye (VTE) with laser photocoagulation in patients with diabetic macular edema (DME).
A total of 221 patients were randomized to 1 of 5 treatment regimens: VTE 0.5 mg every 4 weeks (0.5q4); 2 mg every 4 weeks (2q4); 2 mg for 3 initial monthly doses followed by dosing every 8 weeks (2q8); 2 mg for 3 initial monthly doses followed by dosing as-needed (2PRN); or macular laser photocoagulation. The change in best-corrected visual acuity (BCVA) was measured at week 24, the primary endpoint, and at week 52. Additional secondary endpoints included the proportion of patients who gained ≥15 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters in BCVA and mean changes in central retinal thickness (CRT) from baseline.
Mean improvements in BCVA in the VTE groups at week 24 were 8.6, 11.4, 8.5, and 10.3 letters for 0.5q4, 2q4, 2q8, and 2PRN, respectively, versus 2.5 letters for the laser group (P<0.01 for each VTE group versus laser). Mean improvements in BCVA in the VTE groups at week 52 were 11.0, 13.1, 9.7, and 12.0 letters for 0.5q4, 2q4, 2q8, and 2PRN, respectively, versus -1.3 letters for laser (P<0.0001 for each VTE group versus laser). Proportions of patients with gains in BCVA of ≥15 ETDRS letters in the VTE groups were 41%, 46%, 24%, and 42% versus 11% for laser. Mean reductions in CRT in the VTE groups were -165.4 µm, -227.4 µm, -187.8 µm, and -180.3 µm versus -58.4 µm for laser. VTE was generally well tolerated. The most frequent ocular adverse events were conjunctival hemorrhage, eye pain, ocular hyperemia, and increased intraocular pressure.
Significant gains in BCVA from baseline achieved at week 24 were maintained or improved up to week 52 in all VEGF Trap-Eye groups, including the group receiving 2 mg VTE every other month. VEGF Trap-Eye may have potential benefit in the treatment of DME.
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