Active not recruitingPHASE3INTERVENTIONAL

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)

This research study is investigating a new medication called vonaprument. It's for people who have a severe eye condition known as geographic atrophy (GA), which is a common cause of vision loss in older adults. GA is a type of dry age-related macular degeneration (AMD). The main goal of the study is to find out if receiving monthly injections of vonaprument directly into the eye can help stop or reduce further vision loss due to GA. There will also be a comparison group who receive a 'sham' (inactive) treatment to see the full effect of the new drug. This is a Phase 3 study, meaning it's a later stage of research, usually involving a larger number of participants to confirm the drug's safety and how well it works before it can be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Annexon, Inc.

Enrolment target

659

Start

30 Jul 2024

Estimated completion

31 Jul 2027

Geographic Atrophy

What is this study about?

This research study is focused on a new medicine called vonaprument, which is being tested for a serious eye condition known as geographic atrophy (GA). GA is a more advanced form of dry age-related macular degeneration (AMD). Both GA and AMD affect the macula, a small but very important part of your eye that helps you see fine details and colours, which is crucial for tasks like reading or recognising faces.

At the moment, there isn't a widely available treatment for dry AMD with GA that can stop or reverse the damage. That's why studies like this are so important. They aim to find new ways to protect vision and improve the lives of people living with this condition. This particular study is trying to understand if giving injections of vonaprument directly into the eye every month can help slow down or prevent further vision loss in people with GA.

By comparing the effects of vonaprument with a 'sham administration' (a procedure that looks and feels like the real injection but doesn't contain the active drug), the researchers can get a clear picture of whether vonaprument is truly effective. The results of this study could potentially offer a new treatment option for this challenging eye condition.

Key takeaways

This study is testing a new drug for a severe eye condition called geographic atrophy (GA).
It aims to see if monthly eye injections can reduce vision loss.
Participants will receive either the study drug or an inactive (sham) treatment.
It's a Phase 3 trial, a key step before a drug can be widely used.
The study is for people aged 50 and over with GA caused by dry AMD.

Who may be eligible?

To be considered for this study, you must have been diagnosed with dry age-related macular degeneration (AMD) that has progressed to geographic atrophy (GA). Your local eye doctor and a central team of specialists will both need to confirm this diagnosis.

There are also certain conditions that would prevent you from joining. For example, if your geographic atrophy is caused by other rare eye diseases, such as Stargardt disease, certain types of blindness you're born with, or if it's due to damage from certain medications (like Plaquenil), then you wouldn't be able to participate.

In general, participants need to be 50 years old or older, and both men and women can take part. There will be other specific health requirements mentioned in the full study plan that your doctor will discuss with you.

Quick self-check

Are you 50 years old or older?
Have you been diagnosed with dry age-related macular degeneration (AMD)?
Has your AMD progressed to geographic atrophy (GA)?
Is your GA NOT caused by other eye conditions like Stargardt disease or medication side effects?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would primarily receive monthly injections of either the study medication (vonaprument) or a dummy medication (sham) directly into your eye. You wouldn't know which one you are receiving. These injections would be given regularly over a period of time, along with frequent check-ups at the clinic. These visits will include various eye tests, such as vision checks and detailed eye scans, to monitor your condition and see how the treatment is working.

The total duration of your participation in the study, including all treatments and follow-up appointments, would be explained to you in detail by the study team. You would also have regular health checks to make sure you are doing well throughout the study.

Potential risks and benefits

Taking part in a clinical trial offers the potential to receive a new treatment that isn't yet widely available, which might help slow down vision loss from geographic atrophy. However, there are potential risks, such as side effects from the injections themselves, like temporary discomfort or a small risk of infection. It's also possible that the new treatment may not work for you, or you might end up in the group receiving the inactive treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (132)

Retina Macula Institute of Arizona
Scottsdale, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, United States
Retinal Consultants of Orange County Clinical Research Institute Inc
Fullerton, United States
Global Research Management
Glendale, United States
Retina Consultants Medical Group
Modesto, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, United States
Retinal Consultants Medical Group
Sacramento, United States
Macula Retina Vitreous Research Institute
Torrance, United States
Bay Area Retina Associates
Walnut Creek, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, United States
RSC Research, LLC
Denver, United States
Rand Eye Institute
Deerfield Beach, United States

+120 more sites — see the official record for the full list.

Common questions

What is geographic atrophy (GA)?

Geographic atrophy is a severe form of dry age-related macular degeneration (AMD) that causes blind spots and gradual loss of central vision due to patches of cell death in the retina.

What does 'intravitreal injection' mean?

It means the medicine is injected directly into the jelly-like substance in the middle of your eye (the vitreous) to get to where it needs to work.

What is a 'sham' treatment?

A 'sham' treatment looks and feels like the real injection (e.g., eye drops, a gentle touch) but doesn't actually contain the active study drug. It helps researchers compare the true effect of the medicine.

What is a Phase 3 study?

Phase 3 is a late stage of clinical research where a new treatment is given to a larger group of people to confirm its effectiveness, monitor side effects, and compare it to existing treatments.

How long will the study last?

The full duration of your participation, including treatments and follow-up, will be explained by the study team if you are eligible.