Frequently Asked Questions

Wet AMD happens when abnormal blood vessels leak beneath the retina, damaging central vision, causing distortion, blurry vision, and potential vision loss.

Symptoms include blurred or distorted vision, dark spots or blind spots in the center of vision, decreased ability to recognize faces, and reduced color brightness.

Currently, wet AMD can’t be cured, but current treatments can significantly slow the disease’s progression, potentially preserving or improving vision.

Wet AMD is currently treated with regular anti-VEGF injections into the eye, which help slow or stop abnormal blood vessel growth. These treatments typically require repeated eye injections every few months. While effective at preserving vision, the ongoing schedule can be challenging for patients to adhere to their treatment plan.

Phase 3 studies evaluate the effectiveness and safety of potential new therapies in large patient groups, aiming to confirm benefits seen in earlier studies.

4DMT is the sponsor of the 4FRONT studies. 4DMT is a biopharma company, based in Emeryville, California, developing genetic therapies to potentially treat various diseases. You can learn more about them at www.4dmoleculartherapeutics.com(opens in new tab).

4D-150 is the study drug being tested in the 4FRONT studies. It has not been approved by health regulatory agencies.

4D-150 is a one-time eye injection. It is designed to help the cells in the eye continuously produce their own proteins, which act like tiny helpers that treat wet AMD—potentially reducing the need for frequent injections.

4D-150 is administered in the same way as current standard of care treatments, which is through an Intravitreal (IVT) injection. An IVT injection is given through the white part of the eye, allowing medication to be injected directly into the vitreous humor, the jelly-like substance that fills the eye. An IVT injection is a standard procedure performed in the office by doctors trained on the procedure.

Participation in the 4FRONT studies lasts approximately two years, involving monthly visits for monitoring and assessments.

Absolutely, participants are encouraged to maintain regular visits with their eye care provider throughout the study.

Yes—you can stop participating at any time without impacting your regular eye care.

Gene therapy is a treatment approach that aims to address diseases caused by faulty genes. Genes act as blueprints, providing instructions for making proteins that help the body function properly. When a gene isn’t working correctly, it can lead to disease. Gene therapy works by introducing a healthy copy of the gene into the body’s cells to help them produce the proteins needed to restore function. In the 4FRONT studies, gene therapy is being studied as a potential one-time treatment for wet AMD. The investigational therapy, 4D-150, is injected into the eye to deliver a working copy of the gene. This may help the body produce proteins that target the underlying cause of wet AMD. Because gene therapy is designed to be long-lasting, the effects may be permanent.

Gene therapy uses a special carrier, called a vector, to deliver helpful instructions to cells—similar to how an envelope delivers a message. Some viruses are used as vectors because they are naturally good at entering cells. However, in gene therapy, the harmful parts of the virus are removed, so it cannot cause illness or make copies of itself.

In the 4FRONT studies, the vector carries a working gene and is injected directly into the eye. Once inside, it reaches the retina, where it helps cells produce the right protein to address wet AMD. This process may help manage the disease and potentially reduce the number of anti-VEGF injections in people with wet AMD.

Eligible participants must be at least 50 years of age, diagnosed with wet AMD, and able to commit to study visits approximately once per month for two years.

4FRONT-1 is designed for people who have been diagnosed with wet AMD and have not received wet AMD treatment in the affected eye.

4FRONT-2 is designed for people who have either been diagnosed with wet AMD and have not received treatment for wet AMD in the affected eye or have been diagnosed with wet AMD in the last six months and have not received more than four injections of wet AMD treatment in the affected eye.

Possibly. 4FRONT-1 is for people who have never received wet AMD treatments in the affected eye; 4FRONT-2 is for people who have been recently diagnosed within the past 6 months and have received no more than four previous injections of wet AMD treatment in the affected eye.

Screening visits include thorough medical history reviews, vision assessments, and detailed eye exams to ensure you qualify.

You may receive reimbursement for travel costs to and from the study center, as well as possible compensation for your time per completed study visit. Reimbursements and compensation will be dependent on the rules and guidelines in your area. Additional details may be provided during your screening visit. Please contact a Study Center if you have questions.

Yes, caregivers or family members are encouraged to attend visits with you to offer support, assist with questions, and provide additional comfort. They are also able to accompany you in the transportation provided by the study center, if you choose to use that service.

While there are no guarantees this will help your condition, you will get the chance to actively help advance wet AMD care. Other benefits include receiving close medical monitoring and access to an approved standard of care treatment (aflibercept).

Any significant new information about the study or your treatment will be promptly communicated to you by the study team.

A clinical study is a research study that tests potential treatments to see if they are safe and work well for people. There are four main phases of clinical studies.

Early phases (Phase 1 and Phase 2) are smaller and focus on safety and initial indications of effectiveness.

Phase 3 studies are generally larger and typically test how well the treatment works, which may include comparing the treatment being tested to the current standard of care, while confirming safety.

Phase 4 studies happen after a study drug is approved and continue to test its long-term safety and efficacy. Doctors closely monitor participants throughout any clinical study.

Unlike standard treatments that require regular injections, 4D-150 is designed as a one-time administration, potentially reducing ongoing treatment burden.

No, the 4FRONT studies are “double-masked,” meaning neither you nor your study team knows your assigned treatment, which helps ensure unbiased results.

Some possible side effects include temporary eye irritation, increased eye pressure, inflammation, or infection, all of which are closely monitored by the study team.

If you decide to enroll in a 4FRONT study, you will be given additional information on possible side effects.

No, there is no cost for any study-related treatments, visits, or medications. You may receive reimbursement for travel expenses related to your participation in accordance with rules and guidelines in your area.

You will not know if you receive 4D-150 or the standard of care treatment since the study is “double-masked”. However, if you are randomized to the standard of care treatment group and do not receive 4D-150, you will receive aflibercept injections, which have been approved by health regulatory agencies, at applicable study visits.

The 4FRONT-1 study has centers across the U.S. and Canada, while the 4FRONT-2 study includes locations across the globe.

You’ll typically attend visits at your study center every four weeks for approximately two years, following the initial treatment.

Most visits last a few hours, including assessments, treatments, and monitoring.

Yes, caregivers, family members, or friends are encouraged to join you at visits for support.

Yes, you may receive reimbursement for travel expenses, including travel to and from the study center, depending on your location and preference. Reimbursement will depend on local rules and guidelines in your area.

Yes, you can select the most convenient participating study center near you during the enrollment process.

Generally, participants will attend the same study center throughout the study to ensure continuity of care and accurate monitoring.

After locating the nearest study center through our online locator tool, you’ll find the phone number and ability to send them an email using our online contact form.

If you’re unable to attend a scheduled visit, it’s important to promptly inform your study team they will assist in rescheduling or managing necessary arrangements.

Yes, all participating study centers have qualified, trained staff and procedures in place to manage participant safety and care effectively throughout the study duration.

Participant safety is our top priority. The 4FRONT studies involve thorough health monitoring and are carefully regulated to promptly address any safety concerns throughout the study

Yes, caregivers and family members are encouraged to attend study visits. If needed, they can travel with their loved ones through the travel service provided by the study. Your support helps ensure comfort and clear communication between your loved one and the study team.

No, your loved one can continue regular visits with their own eye specialist and primary care provider. The study team coordinates closely to ensure seamless care.

Caregivers often help with transportation, tracking appointment schedules, or administering eye drops. Clear instructions and support will be provided by the study team.

The study includes regular eye exams, vision tests, and patient questionnaires about overall health and quality of life, ensuring comprehensive health monitoring at every stage of participation.