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J. S. Heier, CLEAR-IT 2 Investigators; CLEAR-IT 2: Phase 2, Randomized, Controlled Dose-and Interval-Ranging Study of Intravitreal VEGF Trap Eye in Patients With Neovascular Age-Related Macular Degeneration: Predictive Factors for Visual Acuity Outcome at One Year. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1255.
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To evaluate potential predictive factors for visual acuity outcomes in patients with neovascular AMD after repeated intravitreal injections of VEGF Trap-Eye over one year.
CLEAR-IT 2 was a double-masked, multi-center Phase 2 trial in AMD patients randomized to receive VEGF Trap-Eye 0.5 or 2.0 mg monthly or 0.5, 2.0, or 4.0 mg quarterly (at baseline and week 12) with monthly reassessment and PRN dosing to 1 year. Subgroups of patients were identified based on age, baseline best-corrected visual acuity (BCVA), baseline lesion size, and previous treatment for neovascular AMD.
Data through one year for all dose groups combined (n=157) demonstrated significant improvement in BCVA (mean increase of 5.3 letters, p<0.0001.) Analyses of the subgroups identified above generated the following results for all treatment groups combined: Patients that were ≤75 years old (n=53) gained an average of 8.26 (±13.55) letters as opposed to those >75 years old (n=104) who gained 3.73 (±13.31) letters (p=0.046). Those with a BCVA ≤54 letters at baseline (n=65) gained an average of 7.54 (±15.44) letters as opposed to those with a BCVA at baseline > 54 letters (n=92) who gained 3.65 (±11.8) letters (p=0.076). Those who began the study with a lesion size ≤4DA (n=124) gained an average of 5.52 (±13.63) letters, while those who began the study with lesions >4DA gained 4.27 (±13.23) letters (p=0.63). Patients who were treatment naïve at the start of the study (n=137) gained an average of 4.8 (±13.7) letters, while those who received previous treatment (n=20) gained an average of 8.4 (±12.09) letters (p=0.27).
In this study, ≤75 years of age at baseline predicted greater visual acuity gains following multiple treatments of VEGF Trap-Eye. In addition, worse baseline visual acuity was suggestive of better visual acuity outcomes. Baseline lesion size and previous treatment status did not significantly affect treatment responses.
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