Introducing SAGA, the Study of ALK-001 in Geographic Atrophy
Geographic Atrophy (GA) is one of the leading causes of blindness. Over one million people in the United States have this condition.
SAGA is a clinical study designed to assess the effects of ALK-001, an investigational oral drug. We will assess if ALK-001 can slow the progression of Geographic Atrophy, and if it can slow the progression from Geographic Atrophy to Wet Age-Related Macular Degeneration (AMD).
Clinical studies, also called clinical trials, are conducted to find out if investigational treatments are safe, effective and medically helpful to patients, so that these treatments can be approved for use in the general population. Clinical studies are organized around a team of healthcare professionals and scientists, including physicians, research coordinators, pharmaceutical companies, etc.
ALK-001 (the investigational drug) is a modified form of vitamin A. Vitamin A is a natural molecule found in food, and is essential for vision. However, during its processing by the eye, vitamin A can form toxic clumps called “vitamin A dimers.” Although the development and progression of AMD and Geographic Atrophy is complex, these clumps are believed by scientists to be one of the factors contributing to vision loss in AMD. ALK-001 acts as a vitamin A replacement and functions just like vitamin A. When taken once a day as a pill, ALK-001 may prevent vitamin A clumps from forming.
Frequently Asked Questions for People Interested in Participating
The clinical study team will discuss in further detail the possible risks and benefits with prospective participants.
There is no guarantee that the study drug is effective, or that you will benefit personally from participating in this study. The study drug may benefit your vision if it is shown to be effective in treating Geographic Atrophy.
Participants’ health will be closely monitored throughout the study. Based on safety data from previous clinical studies, significant side effects are not expected.
- A total of 10 visits will take place during the clinical study, about every 3 months.
- Five visits are short (up to approximately 2 hours) and five are long (up to approximately 4 hours).
- The study doctor may decide to skip some of the short visits.
- If a participant misses a visit it may be rescheduled to a nearby date within the allowed visit window.
- Most procedures performed in the study are already done as part of standard eye care.
- Additional procedures may involve blood draws, visual function tests and filling out questionnaires.
Participants in the SAGA study should:
- Take the study drug once daily.
- Attend all scheduled study visits.
- Inform the clinical study team of any changes in health.
- Not enroll in other clinical trials.
For the most part, participants are allowed to continue taking their normal medications. Participants may also continue taking AREDS2 and supplements that do not contain vitamin A or carotene.
Patients who are at least 60 years old and have been diagnosed with geographic atrophy associated with AMD may be eligible for SAGA. Prospective participants should talk to their doctor and contact the study team to see if they may qualify. Eligibility is ultimately determined by the clinical study team.
Dry-AMD affects ~80-90% of AMD patients and results from the breakdown of light-sensing cells and tissues in retina. The retina is located in the back of the eye. Individuals with dry AMD will lose their vision at a slower pace than those with wet AMD, but dry AMD may continue to progress to legal blindness. There is currently no treatment for dry AMD.
Wet-AMD is a type of AMD where new blood vessels form in the eye and damage vision. Progression of vision loss is rapid when left untreated, but treatments exist to slow or stop the development of these new blood vessels.
There is currently no FDA-approved treatment for geographic atrophy. Some recommendations to manage geographic atrophy include:
- Geographic atrophy patients should stop smoking, and talk to their doctor about dietary changes or about taking AREDS2 supplements. They should also discuss how they can use an Amsler grid to track changes in vision.
- Prospective participants should discuss the diagnosis with their physician to determine if they may be good candidates or benefit from enrolling in a clinical study.
- The following tips may also be helpful for geographic atrophy patients:
- Use a magnifier for reading.
- Use the zoom function on cell phones
- Enlarge fonts on the computer
- Work with vision rehabilitation services that might assist with daily activities.
Interested in SAGA?
Interested in SAGA?
Prospective participants should talk with their family and doctor, meet the SAGA clinical study team to ask questions and determine if they wish to participate in the study.
Still have questions?
Our team is here to help.
The SAGA clinical study is taking place in the United States at multiple clinical study centers. For more information, please contact the sponsor by:
- Telephone: 800-287-2755
- Email: firstname.lastname@example.org
- Contact form: Fill out the contact form below