Efficacy and safety of the intravitreal treatment of diabetic macular edema with pegaptanib: a 12-month follow-up.

Abstract

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.

• Authors: E Pacella, G La Torre, D Impallara, K Malarska, P Turchetti, C Brillante, G Smaldone, G De Paolis, R Muscella, F Pacella
• Journal: La Clinica terapeutica (Clin Ter) Vol. 164 Issue 2 Pg. e121-6 ( 2013) ISSN: 1972-6007 [Electronic] Italy
• PMID: 23698213 (Publication Type: Journal Article)

Chemical References

• Aptamers, Nucleotide
• pegaptanib

Topics

• Aged
• Aged, 80 and over
• Aptamers, Nucleotide (administration & dosage, adverse effects)
• Diabetic Retinopathy (drug therapy)
• Female
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Macular Edema (drug therapy)
• Male
• Middle Aged
• Time Factors
• Treatment Outcome