NCT06664502CompletedPhase 1/2
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 1/2a 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)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 28 Oct 2024
- Start date
- 12 Nov 2024
- Primary completion date
- 25 Mar 2026
- Lead sponsor
- EyeBiotech Ltd.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT06664502
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 38
- From 12 Nov 2024 to the primary completion date, 25 Mar 2026
- 27 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- General Key Inclusion Criteria
- Written informed consent before the first study-related activity
- Be male or female ≥ 18 years of age
- If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential.
- General Key Exclusion Criteria
- Be pregnant or breastfeeding
- Have a history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
- Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest.
- Have had Yttrium-Aluminum Garnet laser capsulotomy in the study eye within 90 days of Screening
- Have had Pan-retinal Photocoagulation or focal thermal laser photocoagulation in the study eye
- Have tractional retinal detachment in the study eye
- Have uncontrolled glaucoma (defined as IOP ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
- BRVO-specific Inclusion Criteria
- Participants must:
- Be diagnosed with BRVO in the study eye
- Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
- Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
- Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO BRVO-specific Exclusion Criteria
- Participants must not:
- Have macular edema in the study eye considered to be secondary to a cause other than BRVO (e.g., DME, Irvine-Gass syndrome)
- Have active iris or angle neovascularization or neovascular glaucoma in the study eye
- Have proliferative retinopathy, central retinal vein occlusion, or hemiretinal vein occlusion
- DME-specific Inclusion Criteria
- Participants must:
- Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
- Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
- Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
- Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of DME
- DME-specific Exclusion Criteria
- Participants must not:
- Have macular edema in the study eye considered to be secondary to a cause other than DME (eg, retinal vein occlusion, Irvine-Gass syndrome)
- Have active iris or angle neovascularization or neovascular glaucoma in the study eye
- Have high-risk proliferative diabetic retinopathy characteristics in the study eye
- NVAMD-specific Inclusion Criteria
- Participants must:
- Be ≥ 50 years of age
- Have a ETDRS BVCA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
- Subfoveal CNV secondary to AMD, with a total lesion size (including blood, scar/atrophy \& neovascularization) of ≤ 9-disc areas, of which at least 50% must be active CNV in the study eye
- Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
- Be treatment naïve with vision loss in the study eye secondary to NVAMD diagnosed within 21 days prior to the Day 1 study treatment NVAMD-specific Exclusion Criteria
- Participants must not:
- Have had previous thermal subfoveal laser therapy in the study eye
- Have any subfoveal atrophy or scarring, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy
- Have had previous photodynamic therapy with Visudyne in the study eye
- Have diabetic retinopathy in the study eye
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arecibo, PR Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Abilene, Texas Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Amarillo, Texas Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Asheville, NC Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Austin, Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Bellaire, Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Bellaire, TX Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Bloomfield, New Jersey Coordinator of this site? Confirm its status | Bloomfield | United States | Unknown status |
| Dallas, Texas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Deerfield Beach, FL Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Germantown, Tennessee Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Hagerstown, Maryland Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Knoxville, TN Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Lemont, IL Coordinator of this site? Confirm its status | Lemont | United States | Unknown status |
| Madison, Mississippi Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Modesto, CA Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Mountain View, California Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Nashville, Tennessee Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Plano, TX Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Round Rock, TX Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Sacramento, California Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sacramento, CA Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| San Antonio, Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Scottsdale, Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Woodlands, Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Wake Forest, NC Coordinator of this site? Confirm its status | Wake Forest | United States | Unknown status |
| West Columbia, South Carolina Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.