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

NCT06664502 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EYE-TIE-201
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 27

Brief 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

BRVO - Branch Retinal Vein Occlusion; Diabetic Macular Edema (DME); Neovascular Age-related Macular Degeneration (NVAMD)

Keywords

DME; Diabetic Macular Edema; NVAMD; Neovascular Age-related Macular Degeneration; BRVO; Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  12 Weeks

Secondary Outcomes (1)

• Best- Corrected Visual Acuity

  12 Weeks

Study Arms (8)

Part 1 MAD - Low Dose

EXPERIMENTAL

Drug: EYE201

Part 1 MAD - Low-Mid Dose

EXPERIMENTAL

Drug: EYE201

Part 1 MAD - Mid-High Dose

EXPERIMENTAL

Drug: EYE201

Part 1 MAD - High Dose

EXPERIMENTAL

Drug: EYE201

Part 2: DME naïve or experienced participants - Dose 1

EXPERIMENTAL

Drug: EYE201

Part 2: DME naïve or experienced participants -Dose 2

EXPERIMENTAL

Drug: EYE201

Part 2: NVAMD naïve or experienced participants - Dose 1

EXPERIMENTAL

Drug: EYE201

Part 2: NVAMD naïve or experienced participants - Dose 2

EXPERIMENTAL

Drug: EYE201

Interventions

EYE201 DRUG

EYE201 solution for intravitreal administration

Also known as: Tiespectus, MK-8748

Part 1 MAD - High Dose; Part 1 MAD - Low Dose; Part 1 MAD - Low-Mid Dose; Part 1 MAD - Mid-High Dose; Part 2: DME naïve or experienced participants - Dose 1; Part 2: DME naïve or experienced participants -Dose 2; Part 2: NVAMD naïve or experienced participants - Dose 1; Part 2: NVAMD naïve or experienced participants - Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• EyeBiotech Ltd.: lead

Study Sites (27)

Scottsdale, Arizona

Scottsdale, Arizona, 85255, United States

Location

Modesto, CA

Modesto, California, 95356, United States

Location

Mountain View, California

Mountain View, California, 94040, United States

Location

Sacramento, CA

Sacramento, California, 95825, United States

Location

Sacramento, California

Sacramento, California, 95841, United States

Location

Deerfield Beach, FL

Deerfield Beach, Florida, 33064, United States

Location

Lemont, IL

Lemont, Illinois, 60439, United States

Location

Hagerstown, Maryland

Hagerstown, Maryland, 21740, United States

Location

Madison, Mississippi

Madison, Mississippi, 39110, United States

Location

Bloomfield, New Jersey

Bloomfield, New Jersey, 07003, United States

Location

Asheville, NC

Asheville, North Carolina, 28803, United States

Location

Wake Forest, NC

Wake Forest, North Carolina, 27587, United States

Location

West Columbia, South Carolina

West Columbia, South Carolina, 29169, United States

Location

Germantown, Tennessee

Germantown, Tennessee, 38138, United States

Location

Knoxville, TN

Knoxville, Tennessee, 37922, United States

Location

Nashville, Tennessee

Nashville, Tennessee, 37203, United States

Location

Abilene, Texas

Abilene, Texas, 79606, United States

Location

Amarillo, Texas

Amarillo, Texas, 79106, United States

Location

Austin, Texas

Austin, Texas, 78705, United States

Location

Bellaire, Texas

Bellaire, Texas, 77401, United States

Location

Bellaire, TX

Bellaire, Texas, 77401, United States

Location

Dallas, Texas

Dallas, Texas, 75231, United States

Location

Plano, TX

Plano, Texas, 75075, United States

Location

Round Rock, TX

Round Rock, Texas, 78681, United States

Location

San Antonio, Texas

San Antonio, Texas, 78240, United States

Location

Woodlands, Texas

The Woodlands, Texas, 77384, United States

Location

Arecibo, PR

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Investigator, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is a multiple ascending dose (MAD) study, and patients will be enrolled sequentially in ascending order through the dose levels until the highest level is reached or until a maximum tolerated dose is reached, whichever comes first. Part 2 is a randomized double-masked study where patients on all arms may be enrolled in parallel.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: November 12, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (26); PR (1)