title: Intravitreal pegaptanib sodium (Macugen®) for treatment of diabetic macular oedema: a morphologic and functional study.
abstract: OBJECTIVE
  To study whether morphologic (foveal thickness, FT) variations of clinically significant macular oedema (CMO) in patients suffering from diabetes following intravitreal pegaptanib sodium (IVP) injection were associated with functional [macular sensitivity (MS) and colour 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. The treatment protocol consisted of three consecutive injections (0.3 mg/0.05 ml; baseline, week 6 and week 12). 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, colour 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 association emphasizes the efficacy of IVP in the treatment of CMO.
authors.affiliation: Dipartimento di Oftalmologia, Seconda Università degli Studi di Napoli, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Flavia
authors.initials: F
authors.lastname: Chiosi
authors.forename: Roberto
authors.initials: R
authors.lastname: dell'Omo
authors.forename: Mario R
authors.initials: MR
authors.lastname: Romano
authors.forename: Francesco
authors.initials: F
authors.lastname: Parmeggiani
authors.forename: Francesco
authors.initials: F
authors.lastname: Semeraro
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Mastropasqua
authors.forename: Ciro
authors.initials: C
authors.lastname: Costagliola
mesh_terms: D000368:Aged; D052157:Aptamers, Nucleotide / Q000008:administration & dosage / Q000627:therapeutic use*; D003118:Color Perception / Q000187:drug effects; D003119:Color Perception Tests / Q000379:methods; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005584:Fovea Centralis / Q000187:drug effects / Q000473:pathology*; D006801:Humans; D058449:Intravitreal Injections; D008137:Longitudinal Studies; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology*
chemical_list: D052157:Aptamers, Nucleotide; D042461:Vascular Endothelial Growth Factor A; C495058:pegaptanib