Not yet recruiting

A study to evaluate the safety and effectiveness of ADX-038 in adults with geographic atrophy caused by age-related macular degeneration.

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on individuals living with Geographic Atrophy, which is an advanced stage of Age-Related Macular Degeneration. This condition involves the progressive loss of cells in the retina, the light-sensitive tissue at the back of the eye, which can lead to a loss of central vision. The purpose of the study is to evaluate the effect of ADX-038 on the growth of these damaged areas in the eye.

Participants in the study will receive either ADX-038 or a placebo through a subcutaneous injection, which is a method of delivering medication into the fatty tissue just beneath the skin. The study will monitor changes in the size of the affected areas and the health of the photoreceptors, which are the specialized cells in the eye that respond to light. This process involves using advanced imaging techniques such as optical coherence tomography, a non-invasive way to take cross-section pictures of the retina, and fundus autofluorescence, a specialized eye imaging test that helps visualize the health of the retinal layers.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation start
The study begins with the administration of either the test medication or a placebo. the placebo is a substance containing sodium chloride (saltwater) that has no active medicinal effect, used to compare results against the test medication.
The test medication, known as adx-038, is administered as a 400 mg injection. this is given through subcutaneous use, which means the injection is placed under the skin.
Step 2
Monitoring and assessment
During the first 12 months, the growth of geographic atrophy (an advanced stage of eye disease) is measured in the study eye. this is done using fundus autofluorescence (FAF), a specialized imaging technique used to look at the retina (the light-sensitive layer at the back of the eye).
The loss of photoreceptors (the cells in the eye that respond to light) is assessed at month 12 and month 24 using optical coherence tomography (oct) and ez mapping. these are imaging methods that provide detailed cross-sectional views of the different layers of the retina.
Step 3
Long-term follow-up
Continued monitoring of the geographic atrophy area is performed through month 24 to evaluate the long-term change in the size of the affected area.
Vision is monitored by measuring letter loss on a standardized eye chart to determine if there is a decline in visual acuity (the clarity of vision) at two consecutive visits or at the end of the study.

Who can join the trial?

19 criteria

You must be between 60 and 100 years old at the time you sign the consent form.
You must have completed specific vaccinations (shots to prevent illness) for Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis at least 2 weeks before starting the study.
You must have received at least 2 doses of the Neisseria meningitidis serotype B vaccine.
You must agree to receive additional vaccine boosters (extra doses to maintain immunity) during the study if required.
Fertile men must use contraception (methods to prevent pregnancy) and must not donate sperm for a specific period during and after the study.
Women who are able to become pregnant must have a negative pregnancy test (a test showing they are not pregnant) using blood and urine, and must use highly effective contraception during the study.
Women who have not had a period for 12 months for medical reasons or are permanently unable to have children are not considered to be at risk of pregnancy.
You must not be breastfeeding.
You must provide written informed consent (a signed document showing you understand and agree to participate) and follow all study rules.
You must have a medical diagnosis of geographic atrophy (GA), which is a form of eye cell loss, caused by age-related macular degeneration (AMD).
Your GA lesions (areas of damaged tissue in the eye) must be a specific size between 2.5 and 12.5 mm² as measured by FAF imaging (a special light test used to look at the retina).
If you have multiple small areas of damage, at least one must be at least 1.25 mm².
At least one area of damage must be located near the fovea (the center part of the retina responsible for sharp vision).
The damaged area must be fully visible on the eye images and not touching the area of peripapillary atrophy (thinning of the tissue around the optic nerve).
There must be a specific pattern of hyperautofluorescence (areas that glow brightly under special light) at the edges of the damaged area.
Your eye scans, specifically OCT imaging (a non-invasive way to take cross-section pictures of the retina), must show specific patterns of loss in the RPE (the layer of cells that supports the retina) and the EZ (the layer responsible for sharp vision).
Your Best Corrected Visual Acuity (BCVA), which is the best vision you can achieve with glasses or contacts, must be at least 24 letters on a standard eye chart.
If the damage is in the very center of your vision (the fovea), your vision must be at least 50 letters on the eye chart.
Your eyes must be clear enough and your pupils (the black center of the eye) must be able to dilate (open wide) enough to allow for high-quality imaging.

Who cannot join the trial?

28 criteria

You cannot participate if your geographic atrophy (a type of eye disease involving the loss of parts of the retina) is caused by something other than age-related macular degeneration, such as Stargardt disease, cone rod dystrophy, or damage caused by certain drugs.
You must not have an active systemic infection (an infection that affects the whole body), including COVID-19, bacterial, or fungal infections, unless you have been fully recovered for at least 14 days.
You cannot have had intraocular surgery (surgery performed inside the eye), such as lens replacement, within the last 3 months.
You cannot have a history of surgical repair for retinal detachment (when the retina pulls away from the back of the eye).
You cannot have aphakia, which is the absence of the lens in the eye.
You cannot have any other eye condition that might require surgery or medical treatment during the study or could affect your ability to see.
You cannot have pathologic myopia, which is an extreme form of nearsightedness that can damage the eye.
You cannot have an active malignancy (cancer) or a history of cancer within the last 5 years, with some specific exceptions for certain skin cancers.
You cannot have previously received any genome-altering therapy, which are treatments designed to change a person's genetic material.
You cannot have used IVT therapy (medication injected directly into the eye) for any reason within the last 6 months in the eye being studied.
You cannot have a known HIV infection.
You cannot have a known or suspected complement deficiency, which is a condition where part of the body's immune system does not work correctly.
You cannot test positive for Hepatitis B or Hepatitis C.
You cannot have liver injury, which is identified by abnormal levels in blood tests that check how well the liver is working.
You cannot have abnormal blood test results, such as very low hemoglobin (a protein in red blood cells that carries oxygen), low platelet counts (cells that help blood clot), or abnormal white blood cell counts (cells that fight infection).
You cannot have used systemic complement inhibitors (medicines that affect the immune system) within the last 6 months.
You cannot have participated in another drug study within the last 90 days.
You cannot be taking any medications that are known to be toxic to the retina (poisonous to the light-sensitive tissue at the back of the eye).
You cannot be taking corticosteroids (steroid medicines) or immunosuppressive agents (medicines that lower the immune system) by mouth, through an injection in the eye, or through a topical application.
You cannot have donated more than 200 mL of blood within the last 30 days.
You cannot have received a blood transfusion within the last 90 days.
You cannot have any other major medical conditions, such as severe kidney disease, advanced heart disease, or severe lung disease.
You cannot have had a major event like a myocardial infarction (heart attack) or a cerebrovascular event (such as a stroke) in the past year.
You cannot have a history of or active CNV (a condition where abnormal blood vessels grow under the retina) related to AMD or any other cause.
You cannot have active eye diseases that affect vision, such as uveitis (inflammation inside the eye), diabetic retinopathy (eye damage caused by diabetes), or uncontrolled glaucoma (increased pressure in the eye).
You cannot have a history of thermal laser therapy (using heat from a laser) in the macula (the central part of the retina responsible for detailed vision).
You cannot have a history of splenectomy (surgical removal of the spleen).
You cannot have active or untreated tuberculosis (a serious bacterial infection).

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
ASST Fatebenefratelli Sacco
Milan, Italy
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Verified
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ADX-038 is an experimental medicine administered as an injection under the skin. It is being studied to see if it can help slow down or prevent the growth of damage in the eye caused by geographic atrophy, a condition related to age-related macular degeneration.

What is already known about the treatment

ADX-038
This investigational drug is administered as an injection under the skin to treat the progression of eye damage caused by age-related macular degeneration. Currently being studied in clinical trials, it belongs to a class of experimental therapies designed to slow down the shrinking of vision in specific areas of the retina. At a molecular level, it works by targeting and managing specific biological processes that lead to the breakdown of retinal cells.
Sodium chloride
This substance is administered as a liquid injection under the skin and serves as a placebo in this study. It is a common salt solution used as a neutral base that does not have a direct therapeutic effect on eye disease. In medical science, it is classified as a solvent used to carry other substances or to provide a baseline for comparison in clinical research.

Investigated diseases

Geographic atrophy secondary to age-related macular degeneration - This condition is a late stage of dry age-related macular degeneration that affects the central part of the eye. It involves the gradual wasting away of the retinal pigment epithelium, which is a critical layer of cells in the retina. As these cells die, the overlying photoreceptor cells also begin to break down. This process leads to the formation of enlarging patches of damaged tissue in the macula. The areas of atrophy typically expand over time, covering more of the retinal surface.