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

May 26, 2026 updated by: EyeBiotech Ltd.

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)

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the multiple ascending dose (MAD) part of the study, 4 cohorts, each comprised of 3 participants, will receive IVT injections of EYE201 at one of 4 dosing levels in ascending order in an open label design. The participants will have previously untreated (naïve) BRVO and will receive EYE201.

Participants will return for safety and efficacy assessments and sample collection study visits. Participants in the following cohort will receive their first IVT injection of EYE201 once all 3 participants in the previous cohort have received their first dose of EYE201 and completed a predefined safety assessment, and a Dose Escalation Committee has confirmed the absence of dose-limiting toxicity (DLT).

Once the last participant in the MAD portion of the study has received their first dose, completed a predefined safety assessment, and the maximum tolerated dose (MTD) either has been determined or declared as not having been reached at the doses tested, 2 of the dose levels will be selected for inclusion in the Part 2 dose-finding study, based on safety and any preliminary efficacy signals observed.

The dose-finding part of the study will be randomized and masked to the participants and study site personnel (except the dose preparer and unmasked injecting physician). The study will be split according to whether the participants have treatment naïve or treatment experienced DME or NVAMD.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Arecibo, PR
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Scottsdale, Arizona
    • California
      • Modesto, California, United States, 95356
        • Modesto, CA
      • Mountain View, California, United States, 94040
        • Mountain View, California
      • Sacramento, California, United States, 95825
        • Sacramento, CA
      • Sacramento, California, United States, 95841
        • Sacramento, California
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Deerfield Beach, FL
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Lemont, IL
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Hagerstown, Maryland
    • Mississippi
      • Madison, Mississippi, United States, 39110
        • Madison, Mississippi
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Bloomfield, New Jersey
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville, NC
      • Wake Forest, North Carolina, United States, 27587
        • Wake Forest, NC
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • West Columbia, South Carolina
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Germantown, Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Knoxville, TN
      • Nashville, Tennessee, United States, 37203
        • Nashville, Tennessee
    • Texas
      • Abilene, Texas, United States, 79606
        • Abilene, Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo, Texas
      • Austin, Texas, United States, 78705
        • Austin, Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire, TX
      • Bellaire, Texas, United States, 77401
        • Bellaire, Texas
      • Dallas, Texas, United States, 75231
        • Dallas, Texas
      • Plano, Texas, United States, 75075
        • Plano, TX
      • Round Rock, Texas, United States, 78681
        • Round Rock, TX
      • San Antonio, Texas, United States, 78240
        • San Antonio, Texas
      • The Woodlands, Texas, United States, 77384
        • Woodlands, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 MAD - Low Dose
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 1 MAD - Low-Mid Dose
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 1 MAD - Mid-High Dose
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 1 MAD - High Dose
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 2: DME naïve or experienced participants - Dose 1
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 2: DME naïve or experienced participants -Dose 2
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 2: NVAMD naïve or experienced participants - Dose 1
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748
Experimental: Part 2: NVAMD naïve or experienced participants - Dose 2
Drug: EYE201
EYE201 solution for intravitreal administration
Other Names:
  • Tiespectus
  • MK-8748

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Best- Corrected Visual Acuity
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeBiotech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Actual)

March 25, 2026

Study Completion (Estimated)

August 11, 2026

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYE-TIE-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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