If Your
Loved One
Has Wet AMD
As a sponsor of the SOL study, we recognize your role as a care partner to be incredibly important for someone with wet AMD. They may need your help with transportation to appointments, understanding their condition and/or the treatment process, or simply knowing what questions to ask. If you’re supporting someone with wet AMD, your consideration is crucial for participation in the SOL study.
Eligibility for this clinical trial depends on several factors, from a potential candidate’s current wet AMD treatment to other medical conditions they may have.1 If eligible, your loved one may have access to an investigational treatment (OTX-TKI).1 Even if they are not in the group that may receive OTX-TKI during the SOL study, their participation may help advance the research of treatments for wet AMD.1,2 It’s important to ask about the risks and benefits of the SOL study to help make the decision together with your loved one.
If you and your loved one decide they should get screened to determine if they can take part in the SOL study, there are several ways you can help them throughout the process if they are eligible to enroll.
01
Review the Informed Consent Form to help answer any questions from your loved one, who may struggle to read the information with their condition and/or comprehend their rights in a clinical trial. You’ll be informed so you and the person with wet AMD can make decisions with confidence.
02
Attend study visits, since participants of the study should not drive for at least 3-4 hours after each visit (possibly longer) due to eye dilation.3 This can help a participant feel supported and more relaxed about the process in general.
03
Be aware of possible side effects to watch out for, to help ensure the study can monitor progression of any side effects.
Please ask the study doctor any questions or concerns you might have about the study; your role as a Care Partner is welcome in the clinical trial process. And remember, if your loved one decides to take part in the SOL study, they can end participation in the study at any time and for any reason.4
Frequently Asked Questions
What is the investigational drug?
The drug component of OTX-TKI is called axitinib and is approved for use in several countries for treatment of a type of kidney cancer called advanced renal cell carcinoma.5
Will the study cost anything?
There will be no charge to anyone for their participation in this study. The investigational drug, study-related procedures, and study visits will be provided at no charge. Additionally, you will receive a stipend for completing the study.3 Ask the study staff for more details.
What are the benefits?
With the help of volunteers, we can work together to further the development of potential treatments for neovascular age-related macular degeneration. The study may not help your loved one directly, but other people with wet AMD may be helped in the future.2
What if my loved one enrolls and then no longer wants to participate?
Taking part in the SOL study is completely voluntary. If enrolled, a participant can choose to end their participation at any time and for any reason.4
Who funds clinical research trials?
Private organizations and government agencies fund, or “sponsor,” clinical trials to find new, and possibly better, ways to treat diseases.2 Working together with medical centers, the government, or doctors’ offices, drug companies sponsor studies of their products to learn more about their safety, effectiveness, and possible side effects.2,6
The SOL study is being sponsored by Ocular Therapeutix, Inc. in Bedford, Massachusetts, USA.1
Learn more by exploring The SOL Trial page of this site, or contact us for additional information.
REFERENCES: 1. Study to evaluate the efficacy and safety of intravitreal OTX-TKI (Ocular Therapeutix) (axitinib implant) in subjects with neovascular age-related macular degeneration. NCT06223958. Updated July 5, 2024. Accessed July 15, 2024. https://clinicaltrials.gov/study/NCT06223958. 2. U.S. Food & Drug Administration. Clinical research versus medical treatment. Updated March 22, 2018. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/clinical-research-versus-medical-treatment. 3. Data on File 01815. Ocular Therapeutix, Inc. 4. U.S. Food & Drug Administration. Informed consent for clinical trials. Updated January 4, 2023. Accessed July 23, 2024. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials. 5. Hsieh JJ, et al. Nat Rev Dis Primers. 2017;3:17009. 6. U.S. Food & Drug Administration. Development & approval process: drugs. Updated August 8, 2022. Accessed July 23, 2024. https://www.fda.gov/drugs/development-approval-process-drugs.