Título / Title

BEVACIZUMAB OR TRIAMCINOLONE FOR PERSISTENT DIABETIC MACULAR A RANDOMIZED CLINICAL TRIAL

Introdução / Purpose

To evaluate the 24-week visual and anatomical effects of “pro re nata” intravitreal bevacizumab (prn-IVB) or quarterly intravitreal triamcinolone (qIVT) in patients who had persistent edema after 24-weeks of prn-IVB therapy.

Material e Método / Methods

Seventy-three patients (100 eyes) with center-involving diabetic macular edema (DME) were enrolled and underwent comprehensive ophthalmologic evaluation at baseline and every 4 weeks up to week 48, including assessment of best-corrected visual acuity (BCVA), lens status evaluation according to lens opacity classification system III (LOCS III), and spectrallis B-scan optical coherence tomography (SB-OCT, Heidelberg, Germany). All enrolled patients received prn-IVB (1.25 mg/0.05 cc) if central subfield foveal thickness (CSFT) was greater than 300µm during the first 24-week study period. At week 24, patients who had persistent edema (CSFT>300) were randomized 1:1 to Group I (prn-IVB therapy) or Group II (qIVT therapy). Patients with CSFT≤300µm at week 24 were comprised to Group III and continued receiving prn-IVB therapy. Retreatment was performed if CSFT>300µm for all groups.

Resultados / Results

56 patients (74 eyes) were enrolled and completed the 48-week follow-up visit. At week 24, 79.3% (65/82) of eyes had CSFT>300µm and were randomized to maintained prn-IVB therapy (Group I, n=33) or switched to qIVT therapy (Group II, n=32). Also 20.7% (17/82 eyes had CSFT≤300µm and continued to receive prn-IVB (Group III, n=17). At baseline, mean CSFT (µm) ± SEM was 447.2 ± 24.4, 478 ± 19.7 and 386 ± 21.0 in groups I, II and III respectively (p>0.05) and there was no significant difference (p=.9998) between groups I (369.9 ± 23.3) and II (426.0 ± 26.1) at week 48 study visit. There was no significant difference on BCVA among group I, II and III at all study follow-up visits (p>0.05).

Discussão e Conclusões / Conclusion

Continued prn-IVB or switched qIVT were associated with similar effects on CSFT and BCVA in persistent chronic DME patients previously treated over 24 weeks of prn-IVB.

Palavras Chave

Diabetic macular edema, Diabetic retinopathy, Intraocular injections