Higher-Dose eye injection may help wet AMD patients who Didn't respond to standard treatments
NCT ID NCT06683950
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests whether switching to a higher dose (8mg) of aflibercept can help people with wet age-related macular degeneration (AMD) who have not responded well to standard treatments like faricimab or the usual 2mg dose of aflibercept. Participants receive up to three injections of the higher dose, and doctors monitor changes in retinal fluid and vision. The goal is to see if this approach can better control the disease with fewer injections.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aflibercept 8mg injection into the eye
- What this could lead to
- If successful, this could offer a more effective treatment option for people with wet AMD who have not responded well to existing therapies, potentially reducing the number of injections needed.
- What could go wrong
- This is a small, early-phase study with only 35 participants, so results may not apply to everyone. The higher dose may also carry unknown risks or side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
35 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
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Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Kim's Eye Hospital
Seoul, Seoul, 150-034, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a One-Time gene injection ease the burden of wet AMD?
- Longer-Lasting eye injection could cut treatment visits for macular disease
- Can a new eye injection save vision in wet AMD?
- Eye injection aims to tame leading causes of blindness
- New eye drug aims to save sight in wet AMD
- Withdrawn study sought better way to time eye injections