Intravitreal pegaptanib sodium (Macugen(®) ) for treatment of diabetic macular oedema: a morphologic and functional study

Abstract AIMS: To study whether morphologic (foveal thickness, FT) variations of clinical significant macular oedema (CMO) in patients suffering from diabetes following intravitreal pegaptanib sodium (IVP) injection were associated to functional (macular sensitivity-MS- and color discrimination, CD) changes. METHODS: A longitudinal, interventional, non randomized study was performed. FT was assessed by optical coherence tomography (OCT); MS by microperimetry, best-corrected visual acuity (BCVA) by early treatment diabetic retinopathy study charts (ETDRS) and CD by Farnswoth-Munsell test. Treatment protocol consisted of 3 consecutive injections (0.3 mg/ 0.05 ml; baseline, 6(th) week and 12(th) week). Follow-up checks were scheduled at, 18-, 24-, 36- and 48-weeks, after injections. RESULTS: Thirty eyes of 30 patients with clinically significant CMO were included for analysis. After IVP a significant decrease of FT occurred with a mean reduction from baseline of 56.9 % (p = 0.0001). An improvement of functional parameters was recorded in all patients (BCVA from 18.2 ± 8.5 letters to 25.5 ± 8.4 letters, p< 0.005; MS from 8.6 ± 2.16 dB to 10.6 ± 2.61 dB, p < 0.001; color analysis from 376.1 ± 125.6 TES to 116 ± 34.6 TES, p = 0.0001). A statistically significant correlation between FT and BCVA as well as MS and CD was also found. Neither ocular nor systemic adverse events were reported. CONCLUSIONS: Intravitreal pegaptanib significantly reduced FT, with a concomitant improvement of MS and CD. This associations emphasizes the efficacy of IVP in the treatment of CMO.