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A Phase 2 Study of Aganirsen Eye Drops to Extend Intravitreal Aflibercept Injection Interval in Patients with Wet Age‑Related Macular Degeneration

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with Wet Age-Related Macular Degeneration experience growth of abnormal blood vessels under the retina, which can lead to blurred or lost central vision. The usual care for this condition involves injections of aflibercept directly into the eye to stop the vessels from leaking. The trial examines whether eye drops containing the experimental drug aganirsen, given at two different strengths, can reduce the need for these injections when compared with placebo drops.

The purpose of the study is to determine if the eye drops allow the interval between injections to be extended. Vision will be measured with a standardized eye chart called the ETDRS chart, which provides a precise reading of visual sharpness. The health of the retina will be monitored using OCT, a non‑invasive scan that creates detailed cross‑section images of the back of the eye. Safety checks will include measuring the eye’s internal pressure (IntraOcular Pressure), assessing tear film stability with the Tear Break-Up Time test, and rating any irritation on a Visual Analog Scale, a simple line where participants indicate how uncomfortable they feel.

Participants will use the assigned eye drops daily for about nine months and will attend regular clinic visits for eye examinations and possible adjustment of injection timing. The study is double‑blind, meaning neither the participants nor the doctors know which drops are being used, and data on injection frequency, visual acuity, retinal thickness, and safety outcomes will be collected at the end of the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit
You will attend the first study visit after you have joined the trial. during this visit a series of eye examinations will be performed, including measurement of visual acuity, optical coherence tomography (oct) imaging of the retina, and assessment of intra‑ocular pressure.
You will receive an intravitreal aflibercept injection of 8 mg. the injection is given directly into the eye using a sterile pre‑filled syringe.
You will be instructed to begin using the study eye drops. depending on the randomization you will receive either aganirsen eye drops at a low or high dose, or a placebo eye drop. the drops will be applied according to the schedule provided for the entire 9‑month treatment period.
Step 2
Regular monitoring visits
You will return to the clinic at scheduled intervals (typically every 4 to 8 weeks) for up to 9 months. at each visit the same eye examinations performed at baseline will be repeated to evaluate any changes in vision, retinal thickness, and the presence of fluid.
The need for additional aflibercept injections will be assessed. the study aims to extend the interval between injections by at least two weeks compared with the baseline schedule.
Your use of the assigned eye drops will be reviewed, and any adverse effects will be recorded.
Step 3
Final assessment
At the 9‑month visit you will undergo the final set of eye examinations, including visual acuity testing, oct imaging, and measurement of intra‑ocular pressure.
If required, a final aflibercept injection will be administered according to the extended interval determined during the study.
Use of the study eye drops will be discontinued after the assessments are completed.
Step 4
Safety follow‑up
One week after the final visit a safety follow‑up will be performed to collect information about any adverse events that may have occurred after stopping the study medication.

Who can join the trial?

8 criteria

Age must be at least 50 years and no older than 89 years.
Must have a confirmed diagnosis of wet age‑related macular degeneration (wAMD) in the eye that will be studied.
Must have received at least one intravitreal injection (a medication shot placed inside the eye) in that eye within the past 48 months after diagnosis.
Currently being treated with intravitreal aflibercept 8 mg (a medication injected into the eye) using a treat‑and‑extend (T&E) dosing regimen in the study eye.
Must have no retinal fluid—meaning no intraretinal fluid (IRF) and no subretinal fluid (SRF)—under the current treatment schedule.
Vision in the study eye must be at least 1/10 on a best corrected visual acuity (BCVA) test.
Must be able to put eye drops in the eye twice daily for 9 months, either by yourself or with a caregiver who can do it for you.
Must have had an unsuccessful attempt to extend the treatment interval because fluid (IRF or SRF) appeared after at least one of the last three injections given with the T&E schedule.

Who cannot join the trial?

6 criteria

You cannot join the study if you have used eye drops that contain steroids (medicines that reduce swelling) or non‑steroidal anti‑inflammatory drugs (pain‑relieving eye drops) in the eye being examined within the last 28 days.
You cannot join the study if you have any other retinal disease (a problem with the back part of the eye) in the eye being examined, besides wet age‑related macular degeneration.
You cannot join the study if the eye you are being studied has significant ocular media opacities (cloudy parts inside the eye, such as cataracts) that could make it hard to measure vision, take detailed eye scans, or check safety.
You cannot join the study if there is any current or recent infection (germ‑related illness) or inflammation (swelling) in or around the eye being studied.
You cannot join the study if you have had a serious heart or blood‑vessel problem in the past six months, such as a heart attack (blocked blood flow to the heart), stroke (blocked blood flow to the brain), transient ischemic attack (a brief, temporary loss of blood flow to the brain), acute congestive heart failure (sudden worsening of the heart’s ability to pump blood), or any other sudden heart‑related event.
You cannot join the study if you are being held in custody or are under psychiatric (mental‑health) care and cannot give your own permission to take part.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Intercommunal Creteil
Creteil, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Centre Hospitalier Universitaire Amiens Picardie
Amiens, France

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Investigated drugs

Aflibercept
is a medication that is injected directly into the eye (intravitreal injection). It works by blocking a protein that causes abnormal blood vessels to grow and leak in the back of the eye, which is a key problem in wet age‑related macular degeneration (wAMD). In this study, all participants receive aflibercept as their standard treatment, and the researchers are looking at how often the injections need to be given while testing another therapy.
Aganirsen
is an experimental eye‑drop treatment that is applied to the surface of the eye. It is being tested to see if it can help patients with wAMD need fewer aflibercept injections by keeping the disease under control for a longer time. The eye drops are given in an emulsion form and are intended to work together with the standard injection therapy to improve patients’ vision health.

What is already known about the treatment

Eylea
This medication is given as a clear liquid that is injected directly into the eye using a pre‑filled syringe. It is an approved drug that has been used for many years to treat wet age‑related macular degeneration and other eye problems. It works by attaching to proteins called VEGF that normally cause new blood vessels to grow, thereby blocking this growth and reducing swelling. It belongs to the class of anti‑angiogenic biologic agents, specifically a VEGF‑binding fusion protein.
Aganirsen
This drug is supplied as eye drops that are placed on the surface of the eye in an emulsion form. It is still experimental and is being studied in clinical trials for wet age‑related macular degeneration. It blocks the production of a protein involved in abnormal eye blood vessel growth by using a short piece of genetic material that interferes with the cell’s instructions. It is classified as an antisense oligonucleotide, an investigational ocular therapy.

Investigated diseases

Wet age-related macular degeneration (wAMD) - Wet age-related macular degeneration is a chronic eye condition in which abnormal blood vessels grow under the central part of the retina (the macula). These new vessels leak fluid and blood, causing swelling and the accumulation of fluid under the retina. The fluid and swelling lead to a gradual loss of sharp, central vision. Over time, the lesions can enlarge, resulting in increasing distortion and blurring of vision. The disease typically develops in older adults and progresses from an early non‑wet stage to the wet stage, with further worsening if left untreated.