Can a new eye injection beat the standard for wet AMD?
NCT ID NCT07798375
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called VIS-101, given as an injection into the eye, for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. Researchers compare two doses of VIS-101 against aflibercept, a standard treatment, to see if VIS-101 can improve or maintain vision with fewer injections. About 244 people who have not yet been treated for this condition will take part. The study measures changes in vision and eye fluid levels over several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VIS-101, an experimental biologic given as an eye injection, compared with aflibercept (Eylea)
- What this could lead to
- If VIS-101 works, it could offer people with wet AMD a treatment that needs fewer eye injections while keeping or improving vision.
- What could go wrong
- This is a phase 2b trial, so VIS-101 is still early in testing. It may not prove better than aflibercept, and eye injections carry risks like infection or retinal detachment.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 244 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Willingness to sign the informed consent form, aged ≥50 years (on Day 0 of dosing), with no gender restrictions 2. Able to adhere to the study protocol per the Investigator judgment 3. Female participants of childbearing potential (WOCBP) or male participants with partners who are WOCBP must agree to use highly effective contraception from screening until 3 months after treatment completion 4. Treatment-naïve CNV secondary to AMD (nAMD) 5. Subfoveal CNV or juxtafoveal/extrafoveal CNV with a subfoveal component related to the CNV activity identified by FFA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyperreflective material, or leakage) confirmed by the Central Reading Center 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis and follow up Exclusion Criteria: 1. Any major illness or major surgical procedure within 1 month before screening in the opinion of the investigator 2. Active cancer within the past 12 months before screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score ≤6 and a stable prostate-specific antigen for \>12 months 3. Requirement for continuous use of any medications and treatments indicated as prohibited therapy 4. Systemic treatment for suspected or active systemic infection on Day 0 Ongoing use of prophylactic antibiotic therapy may be acceptable if approved after discussion with the medical monitor 5. Uncontrolled blood pressure, defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg whilst a participant is at rest on Day 0 6. Stroke (cerebral vascular accident) or myocardial infarction within 6 months before Day 0 7. History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator 8. Pregnancy or breastfeeding, or intention to become pregnant during the study WOCBP must have a negative serum pregnancy test result within 28 days before initiation of study treatment. 9. History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of VIS-101, aflibercept, study-related procedure preparations (including fluorescein and indocyanine green), dilating drops, or any of the anesthetic and anti-microbial drops used by the participant during the study 10. Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months before Day 0 11 Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment (e.g., anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention 12\. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid 13\. Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study 14\. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months before Day 0 15\. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) 16\. Previous periocular pharmacological or IVT treatment (including anti VEGF and/or anti VEGF/ANG2 medications) for other retinal diseases 17\. BCVA of hand motion or worse in the fellow eye 18\. Monocular (no fellow eye) 19\. Any history of idiopathic or autoimmune associated uveitis in either eye 20\. Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 0 21 Aphakic lens status or anterior chamber intraocular lens or an absence of the posterior lens capsule. Previous violation of the posterior capsule is also an exclusion criterion unless it occurred due to prior laser capsulotomy in association with a prior in the bag lens implantation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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