Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere®) in patients with neovascular age‑related macular degeneration
| Autor: | Matias Ramirez Gismondi, Julio Manzitti, Daniel A. Benisek, Romina Quercia, Marcelo A. Tinelli, Andres M. Rousselot Ascarza, María Lourdes Scorsetti, Daniel H. Scorsetti, Maria Penna, Mateo A. Carpio Total, Amalia A. Ascarza, Francisco J. Fernández, Diego Gomez Rancaño, Eduardo Spitzer, Carola Lombas, Matías Deprati |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Cancer Research medicine.medical_specialty Visual acuity genetic structures Injection Procedure Bevacizumab business.industry Conjunctival Hemorrhage General Medicine Intravitreal administration Macular degeneration medicine.disease Clinical trial 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Immunology and Microbiology (miscellaneous) 030220 oncology & carcinogenesis Ophthalmology medicine medicine.symptom Adverse effect business medicine.drug |
| Zdroj: | Experimental and Therapeutic Medicine. 20:1-1 |
| ISSN: | 1792-1015 1792-0981 |
| DOI: | 10.3892/etm.2020.9291 |
| Popis: | The present study was an open-label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere®) administered by the intravitreal route for the treatment of neovascular age-related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti-vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was 'conjunctival hemorrhage' (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of -75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6-month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054). |
| Databáze: | OpenAIRE |
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