title: Efficacy and safety of the intravitreal treatment of diabetic macular edema with pegaptanib: a 12-month follow-up.
abstract: OBJECTIVE
  This observational study was performed to evaluate the efficacy and safety of intra-vitreal injections of pegaptanib during a 12-month follow-up period.
  
  
  METHODS
  Forty eyes (20 patients) affected by diabetic macular edema were monitored. Twenty were subjected to treatment, and 20 were controls. The treatment involved a cycle of three intravitreal injections of pegaptanib (0.3 mg every 6 weeks), at the end of which treated patients were submitted to a monthly follow-up for a period of 12 months. The aim was to evaluate the clinical condition of the eye after therapy and gauge the efficacy of the long-term use of this drug. Specific criteria were used to measure the efficacy and safety of pegaptanib. Regarding efficacy, we considered the following: an average improvement in the power of vision, or visual acuity, of →10 letters (2 lines), equivalent to an average logMAR score of →0.2, and a reduction in the central macular thickness of →250 μm. Regarding safety, we considered the occurrence of undesired eye and systemic side effects correlated to either the drug itself or the injection procedure.
  
  
  RESULTS
  The logMAR score for the measurement of visual acuity at T3 (third intra-vitreal injection at week 13) with respect to T0 decreased from 0.7 ± 0.277 to 0.445 ± 0.216, suggesting an improvement, while the mean Early Treatment Diabetic Retinopathy Study (ETDRS) score increased from 25.75 ± 13.046 to 34.300 ± 11.770 letters. The central macular thickness was reduced from the initial value of 746.95 ± 293.601 to 334.050 ± 93.997 μm. In seven controls, we registered a worsening both in terms of visual acuity and macular thickness in some eyes, justifying a continuation of therapy in eight eyes of the control group.
  
  
  CONCLUSIONS
  Pegaptanib proved to be efficacious and safe for the treatment of diabetic macular edema throughout the 12-month followup. To evaluate its long-term efficacy, further studies are required with larger numbers of patients and longer observational follow-up periods.
authors.affiliation: Department of Sense Organs, Faculty of Medicine and Dentistry, Sapienza University of Rome, Rome, Italy. elena.pacella@uniroma1.it
authors.forename: E
authors.initials: E
authors.lastname: Pacella
authors.forename: G
authors.initials: G
authors.lastname: La Torre
authors.forename: D
authors.initials: D
authors.lastname: Impallara
authors.forename: K
authors.initials: K
authors.lastname: Malarska
authors.forename: P
authors.initials: P
authors.lastname: Turchetti
authors.forename: C
authors.initials: C
authors.lastname: Brillante
authors.forename: G
authors.initials: G
authors.lastname: Smaldone
authors.forename: G
authors.initials: G
authors.lastname: De Paolis
authors.forename: R
authors.initials: R
authors.lastname: Muscella
authors.forename: F
authors.initials: F
authors.lastname: Pacella
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D052157:Aptamers, Nucleotide / Q000008:administration & dosage* / Q000009:adverse effects; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D052157:Aptamers, Nucleotide; C495058:pegaptanib