Título / Title

COMBINED INTRAVITREAL DEXAMETHASONE AND BEVACIZUMAB INJECTION FOR THE TREATMENT OF PERSISTENT DIABETIC MACULAR EDEMA (DEXABE STUDY): A PHASE I CLINICAL STUDY

Introdução / Purpose

To investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BCVA) and central subfield thickness (CSFT) in patients with refractory diabetic macular edema (DME).

Material e Método / Methods

Were included 10 patients (10 eyes) with DME refractory to laser and/or anti-VEGF therapy. Complete ophthalmological evaluation was performed at baseline and after week 1 through week 24. Therapy consisted of monthly injections of combined IVD and IVB “pro re nata” (PRN) if CST > 300 µm. The impact of the injections on IOP, BCVA, cataract development and CSFT at OCT were analyzed.

Resultados / Results

Eight patients (80%) completed 24 weeks of follow-up. Compared to baseline, mean IOP increased significantly (p<0.05) and in 50% of the patients, anti-glaucomatous eye drops were necessary. CSFT reduced significantly at all follow-up visits (p<0,05), although mean BCVA showed no significantly improvement. One patient developed dense cataract progression and another showed vitreoretinal traction at week 24. No inflammation or endophthalmites was observed.

Discussão e Conclusões / Conclusion

PRN IV dexamethasone aqueous-solution plus bevacizumab for refractory DME was associated with adverse effects related to the use of corticosteroids. A transient increase in IOP and cataract progression were observed. There was a significant reduction in central subfield thickness (CSFT) measured on optical coherence tomography and best-corrected visual acuity remained stable or improved in 50% of patients.

Palavras Chave

Diabetic retinopathy; Intravitreal injection; Dexamethasone; Bevacizumab; Triamcinolone; Diabetic macular edema; Optical coherence tomography.

Area

CLINICAL RETINA