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NCT06683950CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
35 (actual)
First submitted
27 Oct 2024
Start date
21 Oct 2024
Primary completion date
14 Jul 2026
Lead sponsor
Kim's Eye Hospital
NCT number
NCT06683950

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 35
  • From 21 Oct 2024 to the primary completion date, 14 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
  • 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.
  • Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.
  • Prior vitrectomy in the study eye
  • Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
  • Prior trabeculectomy or other filtration surgery in the study eye.
  • Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.

Other illness

  • Any history of uveitis in either eye.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
  • Any history of macular hole of stage 2 and above in the study eye.
  • Active ocular or periocular infection in either eye.
  • History of corneal transplant or corneal dystrophy in the study eye.

Other

  • Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
  • Presence of definite chorioretional anastomosis
  • Scar or fibrosis, making up \> 50% of total lesion in the study eye.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  • Active intraocular inflammation in either eye.
  • Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \[YAG\] posterior capsulotomy) in the study eye.

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kim's Eye Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.