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
Public ClinicalTrials.gov record NCT06664502. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06664502
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2024 (Actual)
- Primary completion
- Mar 25, 2026 (Actual)
- Completion
- Aug 11, 2026 (Actual)
- Last update posted
- Aug 24, 2026
2024 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 11
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale, Arizona | Scottsdale | Arizona | 85255 | — |
| Modesto, CA | Modesto | California | 95356 | — |
| Mountain View, California | Mountain View | California | 94040 | — |
| Sacramento, CA | Sacramento | California | 95825 | — |
| Sacramento, California | Sacramento | California | 95841 | — |
| Deerfield Beach, FL | Deerfield Beach | Florida | 33064 | — |
| Lemont, IL | Lemont | Illinois | 60439 | — |
| Hagerstown, Maryland | Hagerstown | Maryland | 21740 | — |
| Madison, Mississippi | Madison | Mississippi | 39110 | — |
| Bloomfield, New Jersey | Bloomfield | New Jersey | 07003 | — |
| Asheville, NC | Asheville | North Carolina | 28803 | — |
| Wake Forest, NC | Wake Forest | North Carolina | 27587 | — |
| West Columbia, South Carolina | West Columbia | South Carolina | 29169 | — |
| Germantown, Tennessee | Germantown | Tennessee | 38138 | — |
| Knoxville, TN | Knoxville | Tennessee | 37922 | — |
| Nashville, Tennessee | Nashville | Tennessee | 37203 | — |
| Abilene, Texas | Abilene | Texas | 79606 | — |
| Amarillo, Texas | Amarillo | Texas | 79106 | — |
| Austin, Texas | Austin | Texas | 78705 | — |
| Bellaire, Texas | Bellaire | Texas | 77401 | — |
| Bellaire, TX | Bellaire | Texas | 77401 | — |
| Dallas, Texas | Dallas | Texas | 75231 | — |
| Plano, TX | Plano | Texas | 75075 | — |
| Round Rock, TX | Round Rock | Texas | 78681 | — |
| San Antonio, Texas | San Antonio | Texas | 78240 | — |
| Woodlands, Texas | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06664502, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06664502 live on ClinicalTrials.gov.