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.
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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)
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Chemical References |
- Aptamers, Nucleotide
- pegaptanib
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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
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