Switching to Aflibercept 8mg for Patients with Limited Response to Previous Treatments
Efficacy of Switching to Aflibercept 8mg in Patients With Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg
This study is testing if switching to a higher dose of Aflibercept can help older patients with neovascular age-related macular degeneration who haven't seen good results from their previous treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Kim's Eye Hospital Academic / other |
| Drugs / interventions | faricimab, Ranibizumab, brolucizumab |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06683950 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Aflibercept 8mg in patients with neovascular age-related macular degeneration (AMD) who have shown limited response to previous treatments with Faricimab or Aflibercept 2mg. The study aims to determine if the new formulation can provide better outcomes in terms of visual acuity and reduce persistent retinal fluid. Participants will be monitored closely to assess changes in their condition and overall response to the treatment. The trial includes patients aged 50 and older who have not achieved satisfactory results from prior therapies.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older diagnosed with neovascular AMD or polypoidal choroidal vasculopathy (PCV) who have shown persistent retinal fluid despite previous treatments.
Not a fit: Patients who have not received prior treatments or those with conditions other than neovascular AMD or PCV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve visual outcomes for patients with neovascular AMD who have not responded well to existing therapies.
How similar studies have performed: While there have been advancements in anti-VEGF therapies, the specific approach of using Aflibercept 8mg in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Seoul, Seoul
- Kim's Eye Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jae Hui kIM, M.D.
- Email: kjh7997@kimeye.com
- Phone: +82-02-2639-7813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.