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
Kim's Eye Hospital
40 participants
Oct 21, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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
Exclusion Criteria20
- 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.
- Any history of uveitis in either eye.
- 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.
- 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 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 history of macular hole of stage 2 and above 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.
- Active intraocular inflammation in either eye.
- Active ocular or periocular infection 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.
- History of corneal transplant or corneal dystrophy in the study eye.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06683950