Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study
| Autor: | Estanislao Gutierrez Sánchez, Jose M Ruiz-Moreno, Monica Asencio-Duran, Jose Garcia-Arumi, FRANCISCO CABRERA LOPEZ, Maria Isabel Lopez |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Vascular Endothelial Growth Factor A medicine.medical_specialty Time Factors Visual acuity genetic structures Visual impairment Visual Acuity Angiogenesis Inhibitors Drug Administration Schedule law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Pro re nata law Ranibizumab Internal medicine Humans Medicine Prospective Studies Dose-Response Relationship Drug business.industry General Medicine Diabetic retinopathy Middle Aged Macular degeneration medicine.disease Ophthalmology Regimen Treatment Outcome Intravitreal Injections Wet Macular Degeneration 030221 ophthalmology & optometry Female medicine.symptom business Tomography Optical Coherence 030217 neurology & neurosurgery Follow-Up Studies medicine.drug |
| Zdroj: | Acta Ophthalmologica. 98 |
| ISSN: | 1755-3768 1755-375X |
| DOI: | 10.1111/aos.14399 |
| Popis: | PURPOSE To assess the noninferiority of the treat-and-extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in naive patients with neovascular age-related macular degeneration (nAMD). METHODS Phase IV, randomized, 12-month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n = 103, T&E, n = 99 or PRN, n = 104. Noninferiority was established at five letters ETDRS. RESULTS The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2-10.2), 6.4 (2.9-9.8), and 8.0 (51.1-11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5-7.7) was similar as compared with the PRN regimen (7.4, 6.7-8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9-9.7) (p |
| Databáze: | OpenAIRE |
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