EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.
In the multiple ascending dose (MAD) part of the study, 4 cohorts, each comprised of 3 participants, will receive IVT injections of EYE201 at one of 4 dosing levels in ascending order in an open label design. The participants will have previously untreated (naïve) BRVO and will receive EYE201. Participants will return for safety and efficacy assessments and sample collection study visits. Participants in the following cohort will receive their first IVT injection of EYE201 once all 3 participants in the previous cohort have received their first dose of EYE201 and completed a predefined safety assessment, and a Dose Escalation Committee has confirmed the absence of dose-limiting toxicity (DLT). Once the last participant in the MAD portion of the study has received their first dose, completed a predefined safety assessment, and the maximum tolerated dose (MTD) either has been determined or declared as not having been reached at the doses tested, 2 of the dose levels will be selected for inclusion in the Part 2 dose-finding study, based on safety and any preliminary efficacy signals observed. The dose-finding part of the study will be randomized and masked to the participants and study site personnel (except the dose preparer and unmasked injecting physician). The study will be split according to whether the participants have treatment naïve or treatment experienced DME or NVAMD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
EYE201 solution for intravitreal administration
Scottsdale, Arizona
Scottsdale, Arizona, United States
Modesto, CA
Modesto, California, United States
Mountain View, California
Mountain View, California, United States
Sacramento, CA
Sacramento, California, United States
Sacramento, California
Sacramento, California, United States
Deerfield Beach, FL
Deerfield Beach, Florida, United States
Lemont, IL
Lemont, Illinois, United States
Hagerstown, Maryland
Hagerstown, Maryland, United States
Madison, Mississippi
Madison, Mississippi, United States
Bloomfield, New Jersey
Bloomfield, New Jersey, United States
...and 17 more locations
Adverse Events
Time frame: 12 Weeks
Best- Corrected Visual Acuity
Time frame: 12 Weeks
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