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NCT06664502 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Diabetic Macular Edema (DME) and BRVO - Branch Retinal Vein Occlusion, sponsored by EyeBiotech.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT06664502: Active Phase 1 study of Diabetic Macular Edema (DME) and BRVO - Branch Retinal Vein Occlusion, sponsored by EyeBiotech.
NCT06664502 is a Phase 1 study of Diabetic Macular Edema (DME) and BRVO - Branch Retinal Vein Occlusion that is active but no longer recruiting, run by EyeBiotech. The registered enrollment target is 38 participants, below the 357-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06664502, a Phase 1 study of Diabetic Macular Edema (DME) and BRVO - Branch Retinal Vein Occlusion, is active but no longer recruiting, sponsored by EyeBiotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG EYE201
Study Locations (20)
California
- Modesto, CA - Modesto
- Mountain View, California - Mountain View
- Sacramento, CA - Sacramento
- Sacramento, California - Sacramento
Texas
- Abilene, Texas - Abilene
- Amarillo, Texas - Amarillo
- Austin, Texas - Austin
- Bellaire, Texas - Bellaire
Tennessee
- Germantown, Tennessee - Germantown
- Knoxville, TN - Knoxville
- Nashville, Tennessee - Nashville
North Carolina
- Asheville, NC - Asheville
- Wake Forest, NC - Wake Forest
Arizona
- Scottsdale, Arizona - Scottsdale
Florida
- Deerfield Beach, FL - Deerfield Beach
Illinois
- Lemont, IL - Lemont
Maryland
- Hagerstown, Maryland - Hagerstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2024-11-12 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What the registry record for NCT06664502 still lists
NCT06664502 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 357-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Diabetic Macular Edema (DME) appearing as the primary indexed condition, and to 1 intervention - of which EYE201 is the first listed.
NCT06664502 names 20 study sites across 11 states, led by California, Texas, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06664502 about?
NCT06664502 is a clinical study titled "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". 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 (MA...
What is the current status of trial NCT06664502?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2024-11-12. Estimated completion is 2026-05-31.
What conditions does trial NCT06664502 study?
This clinical trial studies the following conditions: Diabetic Macular Edema (DME), BRVO - Branch Retinal Vein Occlusion, Neovascular Age-Related Macular Degeneration (NVAMD).
What interventions are being tested in trial NCT06664502?
The interventions under investigation include: EYE201 (DRUG).
Who is sponsoring clinical trial NCT06664502?
This trial is sponsored by EyeBiotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06664502 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06664502's enrollment target sits among peer trials
38 7th of 8 higher than 2 of 8 other Diabetic Macular Edema (DME) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema (DME) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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