Participate in the DR:EAM Study
There is exciting progress happening right in your backyard! The DR:EAM Study is a clinical research study looking at the safety and effectiveness of an investigational topical eye drop in men and women (18 years and over) with diabetic retinopathy (DR). DR occurs when the blood vessels at the back of the eye (the retina) are damaged. Keep reading to learn more about the DR:EAM Study and how you can get involved!
What is the DR:EAM Study?
The DR:EAM Study is a clinical research study with participating sites in Kansas City, looking at the safety and effectiveness of an investigational topical eye drop in men and women (18 years and over) with diabetic retinopathy (DR).
What will Happen During the DR:EAM Study?
The DR:EAM Study will involve a screening period (to check you can join the study) and a study treatment period (where you will receive study drug). You will be asked to self-administer the allocated study drug (either the investigational drug [OTT166] or a matching control) as an eye drop (in the selected study eye) every day, two or four times a day, for 24 weeks. The matching control looks like the investigational drug but contains no active medication. During the study treatment period, you will also be required to visit the study center to have tests/assessments including:
- Examinations and assessments to check your eyes
- A physical examination, including measurement of your height, weight and body temperature
- Measurement of your vital signs (blood pressure and heart rate)
- Blood and urine samples, including a test for pregnancy (if applicable)
- The study team will also discuss your medical history, any current medications you may be taking and how DR affects your daily life
Who qualifies to participate in the DR:EAM Study?
To take part in the DR:EAM Study, you must:
- Be 18 years of age or older
- Have been diagnosed with type 1 or type 1 diabetes mellitus
- Have DR
- Not have received previous treatment for DR
How long will I Stay in the DR:EAM Study?
- While in the study, you will need to take the allocated study drug every day for 24 weeks, unless:
- The study sponsor (OcuTerra) decides to stop the study (due to safety reasonsor for other reasons).
- The study doctor decides it is in your best interest to leave the study.
- You decide to stop participating in the study.*
*Your participation in the DR:EAM Study is entirely voluntary and you are free to leave the study at any time and for any reason. Your decision will not affect any future medical care that you receive.
For more information on the DR:EAM study or other clinical trials in the Kansas and Missouri area, please reach out to our Chapter Clinical Trial Volunteers, Brandee Faille (brandee@tifec.com) and Mark Cagwin (mark.cagwin@ssmhealth.com).