Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study
Abstract Purpose The aim of this study is to investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) in patients with refractory diabetic macular edema (DME) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BC...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | International Journal of Retina and Vitreous |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40942-023-00449-w |
| _version_ | 1797863962558070784 |
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| author | Francyne Veiga Reis Pedro Dalgalarrondo José Edisio da Silva Tavares Neto Murilo Wendeborn Rodrigues Ingrid U. Scott Rodrigo Jorge |
| author_facet | Francyne Veiga Reis Pedro Dalgalarrondo José Edisio da Silva Tavares Neto Murilo Wendeborn Rodrigues Ingrid U. Scott Rodrigo Jorge |
| author_sort | Francyne Veiga Reis |
| collection | DOAJ |
| description | Abstract Purpose The aim of this study is to investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) in patients with refractory diabetic macular edema (DME) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BCVA) and central subfield thickness (CSFT). Methods This prospective study included 10 patients (10 eyes) with DME refractory to laser photocoagulation and/or anti-vascular endothelial growth factor (anti-VEGF) therapy. A complete ophthalmological examination was performed 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 > 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 central sub-foveal thickness (CSFT) measured by spectral-domain optical coherence tomography (OCT). Results Eight patients (80%) completed 24 weeks of follow-up. Compared to baseline, mean IOP increased significantly (p < 0.05) and anti-glaucomatous eye drops were necessary for 50% of the patients, CSFT was significantly reduced at all follow-up visits (p < 0.05), although mean BCVA showed no significant improvement. One patient developed dense cataract progression and another showed vitreoretinal traction at week 24. No inflammation or endophthalmitis was observed. Conclusion Treatment of DME refractory to laser and/or anti-VEGF therapy with combined PRN IV dexamethasone aqueous solution and bevacizumab was associated with adverse effects related to the use of corticosteroids. However, there was a significant improvement in CSFT meantime best-correct visual acuity remained stable or improved in 50% of patients. |
| first_indexed | 2024-04-09T22:44:02Z |
| format | Article |
| id | doaj.art-a8f518eee7e045d0a223c98ec0d58ed0 |
| institution | Directory Open Access Journal |
| issn | 2056-9920 |
| language | English |
| last_indexed | 2024-04-09T22:44:02Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | International Journal of Retina and Vitreous |
| spelling | doaj.art-a8f518eee7e045d0a223c98ec0d58ed02023-03-22T12:00:04ZengBMCInternational Journal of Retina and Vitreous2056-99202023-03-019111010.1186/s40942-023-00449-wCombined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical studyFrancyne Veiga Reis0Pedro Dalgalarrondo1José Edisio da Silva Tavares Neto2Murilo Wendeborn Rodrigues3Ingrid U. Scott4Rodrigo Jorge5Department of Ophthalmology, Ribeirão Preto Medical School, University of São PauloDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São PauloDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São PauloDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São PauloDepartments of Ophthalmology and Public Health Sciences, Penn State College of MedicineDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São PauloAbstract Purpose The aim of this study is to investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) in patients with refractory diabetic macular edema (DME) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BCVA) and central subfield thickness (CSFT). Methods This prospective study included 10 patients (10 eyes) with DME refractory to laser photocoagulation and/or anti-vascular endothelial growth factor (anti-VEGF) therapy. A complete ophthalmological examination was performed 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 > 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 central sub-foveal thickness (CSFT) measured by spectral-domain optical coherence tomography (OCT). Results Eight patients (80%) completed 24 weeks of follow-up. Compared to baseline, mean IOP increased significantly (p < 0.05) and anti-glaucomatous eye drops were necessary for 50% of the patients, CSFT was significantly reduced at all follow-up visits (p < 0.05), although mean BCVA showed no significant improvement. One patient developed dense cataract progression and another showed vitreoretinal traction at week 24. No inflammation or endophthalmitis was observed. Conclusion Treatment of DME refractory to laser and/or anti-VEGF therapy with combined PRN IV dexamethasone aqueous solution and bevacizumab was associated with adverse effects related to the use of corticosteroids. However, there was a significant improvement in CSFT meantime best-correct visual acuity remained stable or improved in 50% of patients.https://doi.org/10.1186/s40942-023-00449-wDiabetic retinopathyIntravitreal injectionAqueous solution of dexamethasoneBevacizumabDiabetic macular edemaOptical coherence tomography |
| spellingShingle | Francyne Veiga Reis Pedro Dalgalarrondo José Edisio da Silva Tavares Neto Murilo Wendeborn Rodrigues Ingrid U. Scott Rodrigo Jorge Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study International Journal of Retina and Vitreous Diabetic retinopathy Intravitreal injection Aqueous solution of dexamethasone Bevacizumab Diabetic macular edema Optical coherence tomography |
| title | Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study |
| title_full | Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study |
| title_fullStr | Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study |
| title_full_unstemmed | Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study |
| title_short | Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study |
| title_sort | combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema dexabe study a phase i clinical study |
| topic | Diabetic retinopathy Intravitreal injection Aqueous solution of dexamethasone Bevacizumab Diabetic macular edema Optical coherence tomography |
| url | https://doi.org/10.1186/s40942-023-00449-w |
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