Working to unlock the mystery of AMD
More than 16 million people in the US have age-related macular degeneration (AMD) with many suffering from moderate vision loss. If you’re on this site, chances are either you or someone you love is currently facing an AMD diagnosis. We are investigating a new treatment for AMD. Our results from Phase 1 are very encouraging. We are currently conducting a Phase 2 clinical trial and looking for candidates for participation. If you’re interested, please choose “Am I a candidate?” and/or contact us and we’ll be happy to discuss the trial with you
The Phase 1 clinical trial for age-related macular degeneration has shown the study medication to be successful and safe. The results showed a decrease in the progression rate of the disease. Therefore, we are conducting a Phase 2 trial and accepting new participants to be a part of the study. As a study participant, you will receive the study medication in our Chicago, Illinois office as well as genetic testing and repeated examinations over the course of two years.
Age-related macular degeneration (AMD) runs in families. If you’re worried about an AMD diagnosis, or concerned you may have AMD, participating in this study may help. We are looking to the future of macular degeneration treatments. Participation means possibilities for generations to come.
Am I a Good Candidate?
We are available to help you to determine if you are a good candidate for the study. Our initial examination will also reveal any study exclusions. However, there are a few main determining factors. You are a good candidate for the study if:
- You are between the ages of 50 and 90 years (for participation in phase 2A); or 65 years of age or older (for participation in phase 2B)
- You have a diagnosis of dry AMD
- You are able to both provide consent for study treatment and can take oral medications
- Age 50-90; Age 65 and older
- Ability to take oral medication
- Ability to provide consent for study treatment
- Diagnosis of dry AMD
- Clinical trial participation in any study within the last 90 days
- Wet AMD
- Previous retinal surgery
- Current malignant cancer diagnosis
- Diagnosis of neurodegenerative disease
- Serious GI issues or conditions (colitis, IBS, etc.)
- Use of blood thinning medications
What to Expect?
As a part of the Insight to Macular Degeneration Study (IMDS), you will receive a series of exams and study-related treatments. This is a randomized study where you will be given one of two study medication regimens. Both regimens are in pill form.
The study lasts for two years. In that time, you will be required to come into our Chicago office for seven study visits where you will be examined to determine how well you are progressing and a series of questions regarding your state of health. Each study visit includes (at no cost to you): an optical coherence tomography (OCT) retinal scan, visual acuity testing and an interview with the study staff.
You can also expect a twice-daily regimen of the study medication(s).
We will call you for an initial screening. During the study you can reach out any time with questions or concerns.
You will have an initial (in-person) visit which will last approximately 1 hour where we will:
- Obtain a complete medical history which involves several questions
- Dilate your pupils
- Conduct retinal imaging
You will have subsequent visits which will last approximately 30 minutes where we will:
- Test visual acuity
- Conduct retinal imaging, dilation may be required
- Ask questions about how you’re feeling (any changes or improvements)
- All study-related treatments will be provided
Paul A. Knepper, MD, PhD
Dr. Paul A. Knepper is chief investigator of the clinical study. As co-partner of Zaparackas & Knepper in Chicago, Dr. Knepper splits his time at his clinical practice and investigating. To learn more about Dr. Knepper please see his full bio.
Zibute G. Zaparackas, MD
Dr. Zibute Zaparackas serves as co-investigator of the clinical study. Dr. Zaparackas is a co-partner of the Chicago-based practice Zaparackas & Knepper. She specializes in pediatric ophthalmology. To learn more about Dr. Zaparackas, please see her full bio.
Frequently Asked Questions
Who is paying for this study?
A company called Zaparackas and Knepper, Ltd., and RQC Prevention, LLC are funding the study.
Will it cost anything to be in this study?
You and/or your health-care payer/insurer will not be billed for the costs of the study. Validated parking may be available and a 24-month supply of study medications will be provided at no cost.
You can ask the study doctor or study staff to find out more about costs.
How long will I be in the study?
If you decide to be in this study and the study doctor says you can be in the study, your participation will last about 24 months (two years).
You will visit the study center to have the procedures and tests. Ask the study doctor or study staff about your study visit schedule.
Will I receive any new information during the study?
If the study doctor or study staff learns any new information that might change your mind about continuing in the study, the study doctor or study staff will tell you about it.
What if I get hurt or sick while I am in this study?
If you experience a change in your health status while participating in the study, please contact the study team to inform them as soon as possible.
Will I receive payment?
You will not receive any payment for your participation in this study.
Do I have to be in this study?
Your participation in this study is voluntary. You can decide not to be in the study, and you can change your mind about being in the study at any time. If you want to stop being in the study, tell the study doctor or study staff.
The study doctor or study staff or sponsor can remove you from the study at any time, even if you want to stay in the study. This could happen if, for example:
- The study doctor or study staff believes it is best for you to stop being in the study.
- You do not follow directions about the study.
- The sponsor stops the study for any reason.
If you stop being in the study early, the study doctor or study staff may ask you some questions about being in the study. The study doctor or study staff may ask you to participate in some procedures or tests to help you leave the study safely and/or to collect more information for the study.
If you leave the study, the study doctor and study staff will still be able to use your information that they have already collected.
How will my information be kept confidential?
Your identity will be protected as required by law and according to any policies the study center or sponsor may have. Be aware that your study records (which includes your information from your medical records, the videos and photos, your signed and dated consent form, and other information) will be shared as needed for the study. For example, the FDA, the sponsor, and Advarra Review may look at your study and medical records.
All video files and OCT image files will be de-identified (coded). The list that matches the code with your name will be stored separately from the files.