Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study)
| Autor: | Andrew N. Antoszyk, Kristin Josic, Michael J. Elman, Adam R. Glassman, John A. Wells, Maureen G. Maguire, Wesley T. Beaulieu, Lee M. Jampol, Jennifer K. Sun, Carl W. Baker |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Vascular Endothelial Growth Factor A medicine.medical_specialty Visual acuity Randomization genetic structures Recombinant Fusion Proteins Visual Acuity Angiogenesis Inhibitors Macular Edema Article law.invention Cohort Studies 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Interquartile range law Internal medicine Ranibizumab medicine Humans 030304 developmental biology Aflibercept Aged 0303 health sciences Diabetic Retinopathy Laser Coagulation business.industry Middle Aged Confidence interval Bevacizumab Ophthalmology Receptors Vascular Endothelial Growth Factor Treatment Outcome Intravitreal Injections 030221 ophthalmology & optometry Female medicine.symptom business Tomography Optical Coherence medicine.drug Cohort study Follow-Up Studies |
| Zdroj: | Ophthalmology |
| ISSN: | 1549-4713 |
| Popis: | Purpose Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial. Design Multicenter cohort study. Participants Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion). Methods Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit. Main Outcome Measures Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST). Results Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0–12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9–9.0) but decreased by 4.7 letters (95% CI, 3.3–6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3–14.5) better than baseline but 4.8 letters (95% CI, 2.5–7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4–5.0) better than baseline but 4.6 letters (95% CI, 3.1–6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142–166) and was stable between 2 and 5 years (−1 μm; 95% CI, −12 to 9). Conclusions Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches. |
| Databáze: | OpenAIRE |
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