Título / Title

INTRAVITREAL PROPRANOLOL ASSOCIATED WITH BEVACIZUMABE FOR EXUDATIVE AGE-RELATED MACULAR DEGENERATION TREATMENT (BEVALOL): PHASE I CLINICAL TRIAL

Introdução / Purpose

To test the safety of intravitreal injection of 0.10 ml of combination of 0.05 ml (1.25 mg) bevacizumab and 0.05ml propranolol (50mcg) to treat active subretinal neovascular membrane in wet age-related macular degeneration (ARMD).

Material e Método / Methods

Prospective phase I clinical trial that included patients with neovascular ARMD. Comprehensive ophthalmic evaluation was performed at baseline and included ETDRS BCVA measurement, anterior and posterior segments biomicroscopy, binocular indirect ophthalmoscopy, color fundus picture, Spectral-domain (SD) OCT, OCT-A, fluorescein angiography (Spectralis, Heidelberg), and full field ERG. All eyes were treated with simultaneous intravitreal injections of 0.05 ml (1.25 mg) bevacizumab and 0.05ml propranolol (50mcg) within 1 week of baseline evaluation. The patients were reexamined at weeks 4, 8 and 12 when SD-OCT was repeated at all follow-up visits. Additional injections of propranolol plus bevacizumab were administered at weeks 4 and 8. At final evaluation (week 12), color fundus picture, OCT-A, fluorescein angiography, and full field ERG were repeated.

Resultados / Results

Eleven patients (11 eyes) completed the 12-week follow-up visit. Full field ERG b-waves did not show significant changes at week 12 when compared to baseline (p<0.05). During the 12-week follow-up period, none of the study eyes developed uveitis, endophthalmitis or IOP increase higher than 4mmhg. At baseline, mean ± standard error best-corrected visual acuity (BCVA) (logMAR) was 0.79 ± 0.09 and a significant improvement in mean BCVA was observed at all study visits (p < 0.05); At baseline, the mean ± SD CSFT (μm) was 462 ± 45. A significant reduction in mean central subfield thickness was observed at all study visits compared with baseline (p < 0.05).

Discussão e Conclusões / Conclusion

After 12 weeks of follow-up, no signals of ocular toxicity or adverse events were found with intraocular use of bevacizumab and propranolol combination. Further studies using this combination are warranted.

Palavras Chave

age-related macular degeneration, VEGF, propranolol, bevacizumab, maculopathy

Area

CLINICAL RETINA