Ask anyone experiencing vision loss due to neovascular, or “wet,” macular degeneration (wAMD) and they’ll tell you that the treatment can be almost as challenging as the disease. The purpose of this clinical study is to research the efficacy, safety and tolerability of an investigational gene therapy treatment for patients with wAMD. This therapy uses proprietary technology to deliver specific transgenes via adeno associated virus (AAV) vectors, directly to retinal cells, with the goal of reducing or potentially eliminating the need for repeated anti-VEGF injections.
How it works
Starting the process only takes a few minutes
Complete The Survey
Answer some brief, easy questions and we’ll let you know whether you may be eligible to participate in the study.
Schedule An Appointment
Speak To A Team Member
Our dedicated specialists understand your situation and will listen, answer any questions, and address your concerns. We’re here to help.
Who Can Participate?
Here are the qualifications participants need to meet in order to join the macular degeneration study:
Be 50 to 89 years old
Have an ETDRS best-corrected visual acuity (BCVA) score between 40 and 78 in one eye
Have been diagnosed with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) in the eye previously treated with anti-VEGF
Learn more about our participation requirements to see if you or your loved one are a good fit for this trial.
Clinical Trials Make A Difference
Your participation in a clinical study may provide information that could lead to a better treatment for wet age-related macular degeneration.
Take Part in Innovation
Shape The Future
Help Others
Understanding Wet AMD
What Is Wet AMD?
Wet age-related macular degeneration (wAMD) is a progressive degenerative macular disease attacking the region of highest visual acuity in the eye (VA), the macula. The neovascular or “wet” form of the disease is characterized by loss of vision due to new, leaky blood vessel formation in the retina, which is a process known as neovascularization. Ultimately, the formation of scar tissue and destruction of photoreceptors results in a severe loss of central vision for sufferers, and eventually an inability to read, write, recognize faces, or drive.
State of Treatment
Current therapies, called anti-VEGFs, are aimed at inhibiting a protein called Vascular Endothelial Growth Factor or VEGF, from binding to its receptor site. VEGF is often over-produced in the eyes of patients with wet macular degeneration and is often responsible for causing abnormal cell growth and vascular leakage. While anti-VEGFs have certainly become common practice in the treatment of wet AMD due to their ability to prevent progression of vision loss in the majority of patients with wet AMD, in order to maintain their efficacy, anti-VEGFs require patients to receive intravitreal injections, typically repeated every four to 12 weeks, for the duration of their lives. Due to this treatment burden, patients often experience a decline in vision with reduced frequency of treatment over time.
What We Hope To Do
The purpose of this clinical study is to research the efficacy, safety and tolerability of an investigational gene therapy treatment for patients with wAMD. This therapy uses proprietary technology to deliver specific transgenes via adeno associated virus (AAV) vectors, directly to retinal cells, with the goal of reducing or potentially eliminating the need for repeated anti-VEGF injections
What are the symptoms of neovascular, or “wet,” age-related macular degeneration?
Signs of wet age-related macular degeneration (wAMD) may include:
Reduced central vision in one or both eyes
Visual distortions, such as straight lines appearing to be bent
Printed words looking blurry
The need for brighter light to assist while reading or doing close-up work
Difficulty adjusting to entering a space with low light levels, like a dimly lit restaurant or theater
Frequently Asked Questions
Who should apply?
You should consider applying for the study if:
- You are between the ages of 50 and 89 years old
- You have an ETDRS best-corrected visual acuity (BCVA) score between 40 and 78 in the study eye
- You have been diagnosed with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) in the eye previously treated with anti-VEGF
- You are pseudophakic at least 12 weeks post-cataract surgery in the study eye
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You have been responsive to anti-VEGF therapy, such as Eylea or Lucentis
What are the benefits?
The information gleaned from this study may help research new treatment options in the future for people with wet age-related macular degeneration. By participating in this study, you will have access to specialists who understand wet Macular Degeneration and can help answer your questions and address concerns.
Are there any risks to participating?
As all drugs and medical procedures carry a risk of side effects, the possibility does exist that participants may experience some discomfort or alternate reaction. The study staff will explain these potential risks before participants decide whether to participate, and address any concerns
What will happen during the study?
As a reminder, the purpose of this study is to evaluate the efficacy, safety and tolerability of an investigational gene therapy in participants with “wet” macular degeneration. You will be asked to attend an initial screening visit to determine if you’re eligible to enroll in the study. We will be evaluating 2 dose levels of the investigational gene therapy relative to an active comparator, in this case a current standard of care therapy called Eylea. If you are enrolled in this study, you will receive either the gene therapy at the outset of the study and will experience a 108-week clinical trial duration with an option to continue for an additional 3 years, or you will begin with anti-VEGF intervention and you will have the option to receive the investigational gene therapy after you have completed 60 weeks of the trial and will be followed for an additional 48 weeks with an option to continue for an additional 3 years after the 108 week timepoint. There is no cost to participate, and participants do not pay for the study medication, clinic visits, or study-related laboratory tests. Do you think you might be interested in participating?
Are there any costs to participate in this study?
No, there is no cost to participate. Qualified participants do not pay for the study medication, clinic visits, or study-related medical procedures and laboratory tests. There is a small patient stipend and if necessary, travel to and from your appointments can be arranged at no cost to you.
Still have questions? Contact us anytime at [email protected]