Actively Recruiting
Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment
Led by Kim's Eye Hospital · Updated on 2024-11-12
40
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures
- Able to read or have the informed consent read to them and understand it
- Signed informed consent form
- Aged 50 years or older
- Diagnosed with neovascular AMD or polypoidal choroidal vasculopathy (PCV)
- Previously treated with faricimab or aflibercept 2mg injections at intervals of 4 to 16 weeks
- Persistent subretinal fluid (SRF) or intraretinal fluid (IRF) after two consecutive faricimab or aflibercept 2mg injections at the same interval
- Central retinal thickness did not decrease by more than 50 micrometers during two consecutive treatments before study entry
- ETDRS best corrected visual acuity letter score of 25 letters or more (approximately 20/320 or better) in the study eye
You will not qualify if you...
- Any prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
- Significant media opacities including cataract in the study eye that may interfere with vision or assessments
- Any other eye condition in the study eye that may increase risk or interfere with injections or evaluations
- Ocular or periocular infection within 2 weeks before screening in either eye
- History of uveitis in either eye
- Presence of definite chorioretinal anastomosis
- Scar or fibrosis covering more than 50% of the lesion in the study eye
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- Retinal pigment epithelial tears or rips involving the macula in the study eye
- History or evidence of diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases besides AMD in either eye
- Any eye condition in the study eye that may require medical or surgical intervention during the 76-week study
- Prior vitrectomy in the study eye
- History of macular hole stage 2 or higher in the study eye
- Intraocular or periocular surgery within 3 months before Day 1 in the study eye, except certain lid surgery
- Prior trabeculectomy or filtration surgery in the study eye
- Uncontrolled glaucoma with intraocular pressure of 25 mmHg or higher despite treatment
- Active intraocular inflammation in either eye
- Active ocular or periocular infection in either eye
- Aphakia or pseudophakia without posterior capsule in the study eye (unless due to YAG capsulotomy)
- History of corneal transplant or corneal dystrophy in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kim's Eye Hospital
Seoul, Seoul, South Korea, 150-034
Actively Recruiting
Research Team
J
Jae Hui kIM, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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