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

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age50+

SponsorKim's Eye Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.

Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.

Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.

Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.

Trial design

Design model

Single group

Treatments tested in this trial

Aflibercept 8mg
Drug
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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Aflibercept 8mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Presence of retinal fluid

To access changes in retinal fluid after switching to aflibercept 8mg in patients who showed limited response to faricimab or aflibercept 2mg treatment in neovascular AMD

Time frame