In a prospective, open-label, non-controlled trial «Chang AA, Li H, Broadhead GK ym. Intravitreal afli...»1 49 patient with treatment-resistant neovascular age-related macular degeneration (AMD) were treated with 2 mg intravitreal aflibercept administered as 3 initial loading doses every 4 weeks, followed by further injections every 8 weeks across a 24-weeks period in total. Outcomes assessed included proportions of patients with a gain or loss of more than 5 ETDSR letters and a decrease or increase in central retinal thickness (CRT) of more than 150 µm at week 24, change in mean best corrected visual acuity (BCVA) and CRT and descriptive safety data. The BCVA improved and CRT was reduced at all follow-up visits compared with baseline (p<0.001), with a mean improvement of 6.9 letters of BCVA and a decrease of 89.4 micrometers in CRT at week 24. There was 1 patient (2%) who lost more than 5 ETDRS letters and 27 (55%) who improved by 5 letters or more. There were 4 serious ocular adverse events, 1 deep vein thrombosis and 1 myocardial infarction.
Total of 26 patients with exudative AMD, previously treated with ranibizumab and/or bevacizumab, were enrolled in a 12-months treatment with 2 mg aflibercept every months for 3 months, followed by a fixed dosing schedule of 2 mg aflibercept every 2 months «Singh RP, Srivastava S, Ehlers JP ym. A single-arm...»2. The primary end point was the mean absolute change from baseline central subfield thickness (CST) at months 12. Secondary outcomes were change from baseline best-corrected visual acuity (BCVA) score, percentage of patients who gained or lost greater than or equal to 15 letters of vision, percentage of patients who are 20/40 or better, percentage of patients who are 20/200 or worse, and the incidence of adverse and serious adverse events. Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 µm (p<0.001) and a mean increase in BCVA of 5.9 letters (p<0.001). Fifteen percent of patients experienced a greater than 15-letter improvement in BCVA, while no patient lost 3 lines on vision. Forty-two percent of subjects were 20/40 or better, and 11.5% of patients were 20/200 or worse at month 6. No serious ocular or systemic adverse events were encountered.
A 12 months follow-up of the patients described above, showed a mean increase in ETDRS BCVA of 9.2 letters (p<0.001) and a mean decrease in CST of 50.3 micrometers (p<0.001) «Singh RP, Srivastava SK, Ehlers JP ym. A single-ar...»3. Twenty-seven percent of subjects experienced a 15-letter or more improvement in visual acuity, and no subject lost 3 lines or more of vision from baseline.
A retrospective survey of 221 patients with wet AMD «Ferrone PJ, Anwar F, Naysan J ym. Early initial cl...»4, who were converted from ranibizumab or bevacizumab to aflibercept (adjusted every 7 weeks without a loading dose), showed no significant improvement in visual acuity or retinal thickness during the first 3 follow-up visits.
Comment: None of these studies report the development of the vision before enrollment in the study.