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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.
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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Arecibo, PR
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AreciboPuerto RicoUnknown status
Abilene, Texas
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AbileneUnited StatesUnknown status
Amarillo, Texas
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AmarilloUnited StatesUnknown status
Asheville, NC
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AshevilleUnited StatesUnknown status
Austin, Texas
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AustinUnited StatesUnknown status
Bellaire, Texas
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BellaireUnited StatesUnknown status
Bellaire, TX
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BellaireUnited StatesUnknown status
Bloomfield, New Jersey
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BloomfieldUnited StatesUnknown status
Dallas, Texas
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DallasUnited StatesUnknown status
Deerfield Beach, FL
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Deerfield BeachUnited StatesUnknown status
Germantown, Tennessee
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GermantownUnited StatesUnknown status
Hagerstown, Maryland
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HagerstownUnited StatesUnknown status
Knoxville, TN
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KnoxvilleUnited StatesUnknown status
Lemont, IL
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LemontUnited StatesUnknown status
Madison, Mississippi
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MadisonUnited StatesUnknown status
Modesto, CA
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ModestoUnited StatesUnknown status
Mountain View, California
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Mountain ViewUnited StatesUnknown status
Nashville, Tennessee
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NashvilleUnited StatesUnknown status
Plano, TX
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PlanoUnited StatesUnknown status
Round Rock, TX
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Round RockUnited StatesUnknown status
Sacramento, California
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SacramentoUnited StatesUnknown status
Sacramento, CA
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SacramentoUnited StatesUnknown status
San Antonio, Texas
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San AntonioUnited StatesUnknown status
Scottsdale, Arizona
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ScottsdaleUnited StatesUnknown status
Woodlands, Texas
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The WoodlandsUnited StatesUnknown status
Wake Forest, NC
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Wake ForestUnited StatesUnknown status
West Columbia, South Carolina
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West ColumbiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.