Goals for the 4FRONT Studies
The 4FRONT studies are Phase 3 clinical studies testing whether 4D-150 is effective and safe in reducing treatment frequency in people with wet AMD.
4D-150 was tested for safety in smaller Phase 1 and Phase 2 clinical studies. More participants are now needed to help gather additional information about whether 4D-150 works, including its effectiveness and safety.
Compare 4D-150 to Current Standard of Care Treatments
Learn whether a single injection of 4D-150 shows similar results to standard of care treatment, including if there is improvement in vision and reducing the number of standard of care treatment injections needed for people living with wet AMD.
Improve Patient Experience
Explore whether fewer injections can improve comfort, convenience, and overall quality of life.
Advance Scientific Knowledge
Gather detailed data about 4D-150’s effectiveness and safety to potentially expand treatment options for people with wet AMD.
What is Wet AMD?
Wet age-related macular degeneration (wet AMD) is an eye condition in older adults in which abnormal blood vessels grow beneath the retina, potentially causing vision loss.
Without treatment, wet AMD can lead to severe vision impairment and/or blindness, impacting everyday tasks like reading and recognizing faces.
Wet AMD Causes and Risk Factors
Wet AMD develops when abnormal blood vessels grow beneath the retina and leak fluid, and impact the macula, the part of the eye responsible for central vision.
- High amounts of a protein called VEGF causes the growth of these abnormal blood vessels
- A risk factor is anything that increases a person’s chances of getting a disease. You may be at an increased risk of wet AMD if:
- Someone in your family also has wet AMD You are 50 years and older
Wet AMD Symptoms
Wet AMD primarily affects central vision, making it harder to read, recognize faces, and perform detailed tasks.
- Blurry or distorted central vision
- Dark spots or blind spots in vision
- Colors appearing dull or less clear
- Difficulty reading, driving, or seeing in low light
Wet AMD Treatments
Current wet AMD treatments usually involve regular eye injections, needed approximately every 4 to 8 weeks, designed to block VEGF proteins to slow vision loss and possibly improve vision. Anti-VEGF injections are the current standard of care (e.g., Aflibercept)
Potential new therapies are being tested in clinical studies (such as 4D-150, being evaluated in the 4FRONT studies)
Meet 4D-150: An Investigational Gene Therapy for Wet AMD
The 4FRONT studies are evaluating an investigational gene therapy called 4D-150. Given as a one-time eye injection, it aims to reduce the frequency of anti-VEGF treatments required to manage wet AMD.
Single, Low Dose
4D-150 is designed as a one-time injection.
Longer-Lasting Potential
4D-150 is designed to help the cells in the eye continuously produce their own proteins to stop the VEGF proteins that cause abnormal blood vessel growth—potentially reducing the need for regular injections.
Convenient for Patients
By aiming to minimize the number of injections needed, 4D-150 may offer participants greater flexibility over their eye care needs.
Who Can Join the 4FRONT Studies?
To ensure participants’ safety and accurate results, the 4FRONT studies have specific qualifications. Review these criteria to see if you or a loved one may qualify.
4FRONT-1
You may be able to join if you:
- Are at least 50 years of age
- Have wet AMD
- Have never received treatment for wet AMD in the affected eye
- Can commit to attending all study visits for approximately two years
4FRONT-2
You may be able to join if you:
- Are at least 50 years of age
- Have wet AMD
- Have been diagnosed with wet AMD and have not received treatment for wet AMD in the affected eye or have been diagnosed with wet AMD within the last six months and have received four or fewer anti-VEGF injections in the affected eye
- Can commit to attending all study visits for approximately two years
What to Expect in the 4FRONT Studies
A participant’s journey throughout the study
If you meet all study requirements and decide to participate, you’ll regularly visit your study center for assessments and treatments. The study team will closely monitor your health, vision, and overall well-being throughout your participation.
Screening Assessments and Eligibility
If you decide to participate, you’ll attend up to 3 screening visits at your study center to confirm eligibility. During these visits, you’ll complete several assessments to ensure you qualify to move forward. If eligible, you’ll receive initial anti-VEGF injections (aflibercept).
Randomization Day
About a week after your second aflibercept injection, you’ll return for your next visit and be randomly assigned to either the 4D-150 study drug group or the standard of care treatment group. If you are randomized to the 4D-150 study drug group, you will receive 4D-150 at the visit. If you are randomized to the standard of care treatment group, you will receive a sham injection (an injection simulation without a needle). This is a double-masked study, meaning neither you nor your study doctor will know your assigned group.
Follow-Up Visits
You will attend monthly follow-up visits for approximately two years.
After you’re randomized, you will receive an aflibercept injection at your first follow up visit regardless of your treatment group assignment.
Beginning at the Week 12 visit, you will either receive an aflibercept or sham injection based on your randomly assigned treatment group. If needed, you may be given aflibercept instead of sham based on the study requirements and the health of your study eye. Both treatment groups will be checked to see if you need an aflibercept injection at visits where aflibercept and sham injections aren’t already scheduled.
Transportation & Reimbursement
You may be compensated for travel expenses related to your study visits, with options including reimbursement for distance driven to and from the study center or transportation services arranged by the study center. All reimbursements and transportation services will be available based on the rules and guidelines in your area. Talk to the study center to learn more about your options.
Supporting Your Loved One Through the 4FRONT Studies
We understand that some people have caregivers that play a crucial role in supporting loved ones living with wet AMD, especially when considering participation in clinical studies. Regardless of whether your loved one receives 4D-150 or the standard of care treatment, their involvement contributes meaningfully to advancing wet AMD research and improving future care.
Informed Decisions
Help your loved one understand study details, their rights as a participant in the study, and what to expect before they enroll.
Visit Support
Assist with monthly appointment scheduling, transportation, and comfort during visits.
Health Monitoring
Be alert to health changes and help your loved one communicate them promptly to the study team.
Helpful Resources
4FRONT-1: Evaluating 4D-150 for Untreated Wet AMD
This is a trifold brochure that goes over the 4FRONT-1 study, which is testing an investigational gene therapy called 4D-150 in adults who have not had treatment for wet AMD in the affected eye.
4FRONT-2: Evaluating 4D-150 for Treated & Untreated Wet AMD
This is a trifold brochure that goes over the 4FRONT-2 global study, which is testing an investigational gene therapy called 4D-150 for people who have been diagnosed with wet AMD, but not yet treated for wet AMD in the affected eye or have been diagnosed with wet AMD within the past six months and have not received more than four injections of wet AMD treatment in the affected eye.