Efficacy and safety of the intravitreal treatment of Diabetic Macular Edema with Pegaptanib: a 12-month follow-up
doi: 10.7417/CT.2013.1543
di
E. Pacella, G. La Torre, D. Impallara, K. Malarska, P. Turchetti, C. Brillante, G. Smaldone, G. De Paolis, R. Muscella, F. Pacella
Aim. This observational study was performed to evaluate the
efficacy and safety of intra-vitreal injections of pegaptanib during a
12-month follow-up period. Patients and 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.
Clin Ter 2013; 164(2):121-126. doi: 10.7417/CT.2013.1543
ATTENZIONE: per accedere al servizio
di consultazione online dei file pdf occorre essere
abbonati alla rivista ed aver abilitato il propriopin.
Se non siete ancora abbonati potete abbonarvi e ricevere il pin attraverso
il nostro online
store.
Per l'attivazione del pin ricevuto, contattare ordini@seu-roma.it.
