IMPORTANCE To our knowledge, this is the first randomized clinical trial to compare visual outcomes and injection loads between ranibizumab and aflibercept using an identical treat-and-extend (TE) regimen for neovascular age-related macular degeneration (nAMD). OBJECTIVE To report the results of the preplanned 12-month interim analysis of 2 predefined secondary efficacy end points of a randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTS The Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients (RIVAL) trial was conducted in 24 sites in Australia and included 281 treatment-naive eyes from 281 participants with active choroidal neovascularization secondary to nAMD and a visual acuity letter score of 23 or greater who were recruited between April 11, 2014, and October 31, 2015. A preplanned interim analysis was performed at month 12. Best-corrected visual acuity (BCVA) assessors and the central reading center, which determined treatment intervals, were masked to treatment assignments. INTERVENTIONS Participants were randomized (1:1) to receive intravitreal injections of 0.5 mg of ranibizumab or 2.0 mg of aflibercept. After receiving 3 initial monthly injections, participants entered the TE phase. MAIN OUTCOMES AND MEASURES Mean change in BCVA and the number of injections from baseline to month 12. RESULTS Of 281 participants, 148 (52.7%) were women and the mean (SD) age was 77.7 (8.1) years. The baseline mean BCVA letter score (approximate Snellen equivalent) was 65.3 (20/50) in the ranibizumab arm and 65.1 (20/50) in the aflibercept arm. One hundred twenty-seven ranibizumab participants (90.1%) and 121 aflibercept participants (88.3%) completed month 12 with a mean (SD [Snellen equivalent]) BCVA letter score of 72.9 (15.5 [20/32]) and 70.5 (14.6 [20/40]), respectively. The mean change in BCVA letter scores from baseline to month 12 was 7.2 (95% CI, 5.5-8.9) for ranibizumab and 4.9 (95% CI, 3.1-6.6) for aflibercept (letter score difference, 2.3; 95% CI, −0.1 to 4.7; P= .06). The mean number of injections from baseline to month 12 was 9.7 in both the ranibizumab (SD, 2.8) and aflibercept (SD, 2.6) arms with a rate ratio of 1.00 (95% CI, 1.0-1.1; P= .86). CONCLUSIONS AND RELEVANCE Our findings suggest that neither aflibercept nor ranibizumab for nAMD are superior to the other regarding the average visual acuity gains and number of injections during 1 year in a TE regimen. Further follow-up to 2 years may determine if advantages of one over the other can be identified.
Aim-To document the nature and frequency of ocular complications in a large group of patients who underwent heart, lung, or liver transplantation. Methods-A retrospective audit of the medical records of all patients undergoing heart, lung, or combined heart-lung transplantation at St Vincent's Hospital, Sydney, or liver transplantation at Royal Prince Alfred Hospital Sydney, was performed to detect patients with symptomatic ocular complications following transplantation. 19 of 860 patients were identified as having ocular complications. Results-Ocular complications occurred in 2% of patients with 65% of these being opportunistic infections. Herpes group viral retinitis (77%) and fungal chorioretinitis (22%) were seen. Other complications included choroidal pseudolymphoma, central retinal vein occlusion, herpes zoster ophthalmicus, herpetic keratitis, dacryocystitis, cyclosporin retinopathy, and rifabutin associated uveitis. Conclusion-Herpes group viral retinitis was the most common ocular opportunistic infection and occurred most frequently during the second year after transplantation. Delayed diagnosis was associated with poor visual outcome. (Br J Ophthalmol 1998;82:423-428)
This study shows that the Inject and Extend protocol is safe and efficacious for the treatment of age-related macular degeneration. Head-to-head studies are needed to compare directly with other regimens currently in use, as well as economic analysis to investigate the financial implications.
Our results with elderly patients in a nursing home show an excellent patient and technique survival and a low peritonitis rate. With appropriate training of the NH nursing staff, peritoneal dialysis could be performed successfully in these nursing homes. Successful peritoneal dialysis in a nursing home requires a close collaboration between the nursing home staff and PD dialysis unit.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.