Combined Intravitreal Dexamethasone and Bevacizumab Injection for the Treatment of Persistent Diabetic Macular Edema (DexaBe Study): A Phase I Clinical Study

Author: Francyne Veiga Cyrino (Brazil)

Co-authors: Pedro Dalgalarrondo, José Edisio Tavares Neto, Murilo Rodrigues, Ingrid Scott, Rodrigo Jorge

Purpose

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

Setting/Venue

Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Brazil.

Methods

This prospective study included 10 patients (10 eyes) with DME refractory to laser and/or anti-vascular endothelial growth factor (anti-VEGF) therapy. The patients underwent a complete ophthalmological examination at baseline, during the first week of treatment, and monthly through week 24. Therapy consisted of monthly injections of combined IVD and IVB “pro re nata” (PRN) if CST higher than 300 µm. We investigated the impact of the injections on intraocular pressure (IOP), cataract development, Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) and CST measured by spectral-domain optical coherence tomography (OCT).

Results

Results: Eight patients (8 eyes, 80%) completed the 24 weeks of follow-up. Mean IOP was significantly (p<0.05 =p inferior to 0,05 ) increased at weeks 1, 16, 20 and 24, compared to baseline and five patients (5/10, 50%) showed sustained increased IOP (higher or igual to 20 mmHg) after week 16, compared to the baseline visit and required IOP-lowering eye drops. Although CSFT had reduced significantly at all follow-up visits compared to baseline (p<0,05 = p inferior to 0,05), mean BCVA was not significantly improved compared to baseline at any of the follow-up visits. One patient who experienced cataract progression which precluded OCT evaluation at week 20 was referred for phacoemulsification; another patient showed vitreoretinal traction with increased CSFT at week 24 and was referred for vitreoretinal surgery. No intraocular inflammation was observed.

Conlusions

Conclusion: Treatment of DME refractory to laser and/or anti-VEGF therapy with PRN combined IV dexamethasone aqueous-solution and bevacizumab was associated with adverse effects typically related to the use of corticosteroids, and was associated with significant improvement in CSFT, although improvement in BCVA was not observed.

Financial Disclosure

No financial interest