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RECRUITING
NCT06683950
PHASE4

Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment

Sponsor: Kim's Eye Hospital

View on ClinicalTrials.gov

Summary

The treatment landscape for neovascular AMD has evolved with various anti-VEGF agents since 2006. Ranibizumab initially led the way, but its limited efficacy in reducing retinal edema paved the way for aflibercept in 2011, which became globally popular for its effectiveness and safety. Yet, aflibercept did not fully meet all patients' needs. In 2019, brolucizumab showed promising anatomical results but had higher risks of inflammation, limiting its use. Faricimab, introduced in 2022, aimed for longer-lasting effects by targeting VEGF-A and angiopoietin 2. Though it required fewer injections, questions remain about its long-term efficacy compared to aflibercept. Despite recent advancements, no agent has established itself as the new standard since aflibercept's introduction, leaving significant unmet needs. Aflibercept 8mg, approved in 2023, has shown promise by matching long-term visual outcomes of aflibercept 2mg with fewer injections and comparable safety. This study examines the effects of switching to aflibercept 8mg for patients with a limited response to previous treatments, addressing the potential for aflibercept 8mg to meet current needs more effectively and providing timely data for its global rollout.

Official title: Efficacy of Switching to Aflibercept 8mg in Patients With Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-10-21

Completion Date

2026-05-31

Last Updated

2024-11-12

Healthy Volunteers

No

Interventions

DRUG

Aflibercept 8mg

Switching to intravitreal aflibercept 8mg in patients previously treated with faricimab or aflibercept 2mg. The dosing schedule is as follows. 1. A single dose of 8mg aflibercept was administered to all patients 2. After treatment 1, follow-up observations were conducted at the same intervals as previous treatments. If complete fluid resolution (no evidence of SRF or IRF) is observed, an additional dose of 8mg aflibercept is administered, extending the dosing intervals by two weeks each time. 3. Up to three doses of 8mg aflibercept can be administered. 4. If, after the administration of 8mg aflibercept, follow-up observations reveal remaining SRF or IRF, the study concludes without additional dosing.

Locations (1)

Kim's Eye Hospital

Seoul, Seoul, South Korea