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ACTIVE NOT RECRUITING
NCT06664502
PHASE1/PHASE2

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

Sponsor: EyeBiotech Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion (BRVO), and a Dose-finding, Double-masked, Comparative Safety, and Preliminary Efficacy Study of Intravitreal (IVT) EYE201 (Tiespectus) in Participants With Either Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2024-11-12

Completion Date

2026-05-31

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

EYE201

EYE201 solution for intravitreal administration

Locations (27)

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

Asheville, NC

Asheville, North Carolina, United States

Wake Forest, NC

Wake Forest, North Carolina, 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