Home › Trials › NCT06664502

Investigating a new drug for eye conditions related to macular edema

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)

Phase1; Phase2 Interventional EyeBiotech Ltd. · NCT06664502

This study is testing a new eye drug called EYE201 to see if it can help people with macular edema caused by certain eye conditions feel better and improve their vision.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment92 (estimated)
Ages18 Years and up
SexAll
SponsorEyeBiotech Ltd. Industry-sponsored
Locations27 sites (Scottsdale, Arizona and 26 other locations)
Trial IDNCT06664502 on ClinicalTrials.gov

What this trial studies

This clinical trial consists of two parts aimed at evaluating the safety and preliminary efficacy of a new drug called EYE201 for patients with macular edema due to branch retinal vein occlusion, diabetic macular edema, or neovascular age-related macular degeneration. In the first part, participants with branch retinal vein occlusion will receive escalating doses of EYE201 to assess safety. The second part will involve a randomized, masked comparison of two selected doses of EYE201 in patients with diabetic macular edema or neovascular age-related macular degeneration, with participants receiving a total of three injections spaced four weeks apart.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with treatment-naïve branch retinal vein occlusion, diabetic macular edema, or neovascular age-related macular degeneration.

Not a fit: Patients with a history of certain eye surgeries, uncontrolled blood pressure, or other specific ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from macular edema, potentially improving their vision and quality of life.

How similar studies have performed: Other studies have shown promise with similar approaches in treating macular edema, but the specific drug EYE201 is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Scottsdale, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Macular EdemaNeovascular Age-related Macular DegenerationBRVO - Branch Retinal Vein OcclusionDMENVAMDBRVOBranch Retinal Vein Occlusion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.