Home
Clinical Trials
A 2-part Study Consisting of ...

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

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

NCT05919693

Neovascular Age-related Macular Degeneration (NVAMD) Diabetic Macular Edema (DME)

COMPLETED PHASE1/PHASE2

Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

NCT03790852

TERMINATED PHASE1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

NCT06847854

Diabetic Macular Edema

ACTIVE_NOT_RECRUITING PHASE1

Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

NCT06550011

Neovascular (Wet) AMD

RECRUITING PHASE1/PHASE2

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients

NCT04635800

Macular Edema Diabetic Macular Edema Neovascular Age-related Macular Degeneration +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participant, Investigator, Outcomes Assessor

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.