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Can a higher dose of an existing eye drug cut injection frequency for wet AMD?

NCT ID NCT07728981

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial is investigating whether a higher 8 mg dose of aflibercept, given every three months, can effectively control wet age-related macular degeneration (nAMD) in people who have not been treated before. The study will measure changes in eye fluid biomarkers, vision, and safety over 12 months. If the modified dosing works, it could mean fewer injections for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept 8 mg eye injection
What this could lead to
If successful, this dosing schedule could offer people with wet AMD a more convenient treatment option with fewer clinic visits.
What could go wrong
This is a small, early-phase study, so results may not apply to all patients. Higher doses may carry increased risk of eye inflammation or other 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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 49 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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 to 85 years

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who fully understand the content, procedures, and possible adverse events (AEs) of this study and are able to provide written informed consent; 2. Male or female patients aged ≥50 years at the time of signing the informed consent; 3. Women of childbearing potential (WOCBP) must agree to use dual contraception during the study and for 4 months after discontinuation of study treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom). Women who have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or menopause for more than 1 year are considered not of childbearing potential. Women of childbearing potential must have a negative pregnancy test at screening and must not become pregnant, breastfeed, lactate, or plan pregnancy, breastfeeding, or egg donation during the study and for 4 months after discontinuation of study treatment; 4. Male subjects whose partners are of childbearing potential must agree to use dual contraception during the study and for 4 months after the end of treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom), and must agree not to donate sperm during the study and for 4 months after the end of treatment. Inclusion Criteria for Study Eye Subjects included in this study must meet all of the following ocular inclusion criteria for the study eye: 5. Have sufficiently clear ocular media and adequately dilated pupils to obtain high-quality retinal images for diagnosis; 6. Untreated nAMD with active subfoveal choroidal neovascularization (CNV), with total CNV area accounting for more than 50% of the total lesion area. 7. SD-OCT examination showed the presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the foveal center of the retina. 8. During the screening and baseline periods, BCVA scores measured using the ETDRS visual acuity chart at an initial testing distance of 4 meters ranged from 78 to 24 ETDRS letters (inclusive) (approximately equivalent to Snellen visual acuity 20/32 to 20/320), and the vision loss was caused by nAMD. Exclusion Criteria: 1. Patients who have received other investigational treatments (including anti-VEGF, corticosteroids, laser photocoagulation treatments \[panretinal photocoagulation or macular photocoagulation\], and photodynamic therapy \[PDT\]) or approved nAMD drugs/therapies; 2. Patients with allergies or hypersensitivity reactions to any component/excipient of the investigational product; 3. Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg). Subjects may be treated with up to three known antihypertensive drugs to achieve adequate blood pressure control. This restriction applies to drugs that can be used for treating hypertension, even if the primary purpose of taking the drug for the subject is not blood pressure control. Any medication known to affect blood pressure must have a stable regimen for 12 weeks prior to screening; 4. History of other diseases, metabolic dysfunctions, abnormal physical examinations, or clinical laboratory abnormalities that reasonably suggest a contraindication to the investigational drug, may interfere with the interpretation of study results, or could place the patient at high risk for treatment-related complications; 5. Any condition that, in the opinion of the investigator, may affect the patient's ability to provide informed consent, comply with the study protocol, complete the study according to study procedures, or for which the patient's participation may affect the study results or their own safety; Exclusion criteria for study eye 6. Any eye with diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than nAMD; 7. Presence of extraocular/periocular infection or inflammation in any eye during the screening or baseline period; 8. Presence of retinal pigment epithelium (RPE) tear or rupture, scarring, fibrosis, or atrophy involving the fovea; 9. Fluorescein angiography (FA)/fundus photography (FP) showing: 1. Total lesion area (including hemorrhage, scarring, and neovascularization) greater than 12 disc areas (30.5 mm²); 2. Fibrosis or atrophy \>50% of the total lesion area, and/or involving the fovea. 10. Any intraocular disease that the investigator believes may reduce vision improvement or require medical or surgical intervention during the study (such as amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction): 1. Presence of vitreous hemorrhage during the screening or baseline period; 2. Uncontrolled glaucoma (intraocular pressure still \>25 mmHg despite anti-glaucoma medication); 3. Any cataract surgery or treatment for cataract surgery complications with steroids or yttrium-aluminum garnet (YAG) laser capsulotomy within 3 months prior to Day 1 of the study; 4. Any prior intraocular surgery (e.g., vitrectomy, glaucoma surgery, corneal transplantation, or radiation therapy); 5. Prior periocular or intravitreal drug injections (including anti-VEGF agents) for other retinal diseases; 6. Presence of intraocular inflammation/infection in any eye within 12 weeks prior to the screening visit; 7. History of idiopathic or autoimmune-related uveitis in the study eye.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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