A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
- Conditions
- Diabetic Macular Edema (DME)Neovascular Age-related Macular Degeneration (NVAMD)BRVO - Branch Retinal Vein Occlusion
- Interventions
- Registration Number
- NCT06664502
- Lead Sponsor
- EyeBiotech Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: DME naïve or experienced participants -Dose 2 EYE201 - Part 2: NVAMD naïve or experienced participants - Dose 1 EYE201 - Part 1 MAD - Low Dose EYE201 - Part 1 MAD - Low-Mid Dose EYE201 - Part 1 MAD - Mid-High Dose EYE201 - Part 1 MAD - High Dose EYE201 - Part 2: DME naïve or experienced participants - Dose 1 EYE201 - Part 2: NVAMD naïve or experienced participants - Dose 2 EYE201 -
- Primary Outcome Measures
Name Time Method Adverse Events 12 Weeks
- Secondary Outcome Measures
Name Time Method Best- Corrected Visual Acuity 12 Weeks
Trial Locations
- Locations (27)
Lemont, IL
🇺🇸Lemont, Illinois, United States
Asheville, NC
🇺🇸Asheville, North Carolina, United States
Wake Forest, NC
🇺🇸Wake Forest, North Carolina, United States
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
Hagerstown, Maryland
🇺🇸Hagerstown, Maryland, United States
Madison, Mississippi
🇺🇸Madison, Mississippi, United States
Bloomfield, New Jersey
🇺🇸Bloomfield, New Jersey, United States
West Columbia, South Carolina
🇺🇸West Columbia, South Carolina, United States
Germantown, Tennessee
🇺🇸Germantown, Tennessee, United States
Knoxville, TN
🇺🇸Knoxville, Tennessee, United States
Nashville, Tennessee
🇺🇸Nashville, Tennessee, United States
Abilene, Texas
🇺🇸Abilene, Texas, United States
Amarillo, Texas
🇺🇸Amarillo, Texas, United States
Austin, Texas
🇺🇸Austin, Texas, United States
Bellaire, Texas
🇺🇸Bellaire, Texas, United States
Bellaire, TX
🇺🇸Bellaire, Texas, United States
Dallas, Texas
🇺🇸Dallas, Texas, United States
Plano, TX
🇺🇸Plano, Texas, United States
Round Rock, TX
🇺🇸Round Rock, Texas, United States
San Antonio, Texas
🇺🇸San Antonio, Texas, United States
Woodlands, Texas
🇺🇸The Woodlands, Texas, United States
Arecibo, PR
🇵🇷Arecibo, Puerto Rico