Age-Related Macular Degeneration (ARMD) Clinical Trials

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Efficacy of Switching to Aflibercept 8mg in Patients with Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.

• Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

• Signed informed consent

• Patients aged 50 years or older

• Patients diagnosed with neovascular AMD or PCV

• Patients underwent faricimab or aflibercept 2mg injections with an inverval of 4 to 16 weeks

• Patients who continued to show persistent subretinal fluid (SRF) or intraretinal fluid (IRF) despite receiving two consecutive faricimab or aflibercept 2mg injections at the same injection interval.

• In cases where the central retinal thickness did not decrease by more than 50 μm during two consecutive treatments prior to inclusion in the study

• ETDRS BCVA letter score ≥25 letters (approximately 20/320 or better) in the study eye

Locations
Other Locations
Republic of Korea
Kim's Eye Hospital
RECRUITING
Seoul
Contact Information
Primary
Jae Hui kIM, M.D.
kjh7997@kimeye.com
+82-02-2639-7813
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 40
Treatments
Experimental: Aflibercept 8mg
In cases where patients previously treated with faricimab or aflibercept 2mg were switched to aflibercept 8mg
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Papilledema
Sponsors
Leads: Kim's Eye Hospital

This content was sourced from clinicaltrials.gov

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