The Center for Research & Clinical Trials:
The Eye Institute for Medicine & Surgery is currently enrolling patients for the ALTISSIMO research study for people living with neovascular age-related macular degeneration, commonly known as wet AMD. The study is evaluating the safety and effectiveness of an investigational drug that may offer the potential for people living with wet AMD to have fewer injections than the current standard of care options. Read more below to find out if you might be a candidate.
Who is eligible to participate in the ALTISSIMO Study?
To pre-qualify for this study, you must meet the following criteria:
- Be at least 50 years of age
- Have been diagnosed with wet AMD
- Meet additional requirements as determined by a screening process
Full study participation includes about 15 visits to a study center for screening, treatments, and assessments and is expected to last up to approximately 13 months.
All study-related mvisits, tests and medications will be provided at no cost to you.
In addition, reimbursement for study-related time and travel may be provided.
What Happens During the ALTISSIMO Detailed Screening?
After signing the consent form, you will begin your study participation by undergoing the detailed screening procedures and assessments. You will also be asked about your medical history, previous AMD treatments, medications you have taken, and other issues that may affect your ability to participate in the study.
What Happens During the ALTISSIMO Study Visits?
After screening, if you qualify and choose to enroll, you will return to The Center for Clinical Trials at The Eye Institute for scheduled study visits over the next year. At some visits, you will be administered your assigned study drug. At all visits, you will undergo safety, clinical, and imaging assessments. Study visits are required and help the study doctor monitor your health and well-being. Visits also give you a chance to ask questions.
What Are My Responsibilities in the ALTISSIMO Study?
The study depends on the cooperation of study participants. If you join the study, you will need to:
- Attend all study visits as scheduled and undergo study procedures and assessments.
- Ask the study doctor and staff any questions you may have throughout the study.
- Talk to the study doctor and staff BEFORE you take any new medications or supplements or have any medical procedures during this study.
- Tell the study doctor and staff about changes in your vision or how you feel.
- Call The Center for Clinical Trials at The Eye Institute right away to reschedule a visit if you can’t make your appointment
What Are the Benefits and Risks Related to the ALTISSIMO Study?
While it is possible you could benefit from participating in this study, that cannot be guaranteed. It is also possible you could experience a side effect while in this study. The study staff will review the full list of risks and side effects with you before you join the study.
Because research studies can affect your health and safety, you will be monitored while you are in this study. The sponsor of this study was required to design a protocol, which explains all study procedures in detail. An independent review board responsible for participant safety reviewed this protocol and requires that it be followed exactly.
Ready to Learn More?
Call us at 321-722-4443, wait for the recording to begin and then dial *136 to speak with a study coordinator. Additional information advailable at altissimostudy.com