Diabetic Macular Edema (DME)Phase 1/2NCT06664502
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 1/2 study testing EYE201 in people with Diabetic Macular Edema (DME) and Neovascular Age-related Macular Degeneration (NVAMD), run by EyeBiotech Ltd. at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
- What is being tested?
- EYE201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 12 Nov 2024to 11 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
Abilene, Texas
Abilene, Texas, 79606
Amarillo, Texas
Amarillo, Texas, 79106
Asheville, NC
Asheville, North Carolina, 28803
Austin, Texas
Austin, Texas, 78705
Bellaire, Texas
Bellaire, Texas, 77401
Bellaire, TX
Bellaire, Texas, 77401
Bloomfield, New Jersey
Bloomfield, New Jersey, 07003
Dallas, Texas
Dallas, Texas, 75231
Deerfield Beach, FL
Deerfield Beach, Florida, 33064
Germantown, Tennessee
Germantown, Tennessee, 38138
Hagerstown, Maryland
Hagerstown, Maryland, 21740
Knoxville, TN
Knoxville, Tennessee, 37922
Lemont, IL
Lemont, Illinois, 60439
Madison, Mississippi
Madison, Mississippi, 39110
Modesto, CA
Modesto, California, 95356
Mountain View, California
Mountain View, California, 94040
Nashville, Tennessee
Nashville, Tennessee, 37203
Plano, TX
Plano, Texas, 75075
Round Rock, TX
Round Rock, Texas, 78681
Sacramento, CA
Sacramento, California, 95825
Sacramento, California
Sacramento, California, 95841
San Antonio, Texas
San Antonio, Texas, 78240
Scottsdale, Arizona
Scottsdale, Arizona, 85255
Woodlands, Texas
The Woodlands, Texas, 77384
Wake Forest, NC
Wake Forest, North Carolina, 27587
West Columbia, South Carolina
West Columbia, South Carolina, 29169
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
- Being tested
- EYE201
- Keywords
- DME, Diabetic Macular Edema, NVAMD, Neovascular Age-related Macular Degeneration, BRVO, Branch Retinal Vein Occlusion
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYE201Drug
Also called Tiespectus, MK-8748
EYE201 solution for intravitreal administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1 MAD - Low Dose | Experimental | Not described Receives: Drug: EYE201 |
| Part 1 MAD - Low-Mid Dose | Experimental | Not described Receives: Drug: EYE201 |
| Part 1 MAD - Mid-High Dose | Experimental | Not described Receives: Drug: EYE201 |
| Part 1 MAD - High Dose | Experimental | Not described Receives: Drug: EYE201 |
| Part 2: DME naïve or experienced participants - Dose 1 | Experimental | Not described Receives: Drug: EYE201 |
| Part 2: DME naïve or experienced participants -Dose 2 | Experimental | Not described Receives: Drug: EYE201 |
| Part 2: NVAMD naïve or experienced participants - Dose 1 | Experimental | Not described Receives: Drug: EYE201 |
| Part 2: NVAMD naïve or experienced participants - Dose 2 | Experimental | Not described Receives: Drug: EYE201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 12 Weeks
Secondary outcomes (1)
Best- Corrected Visual Acuity
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start12 Nov 2024
- Primary completion25 Mar 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeBiotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664502
- Sponsor's protocol ID
- EYE-TIE-201
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06664502
- Acronym / sponsor ID
- EYE-TIE-201
- Conditions
- Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
- Keywords
- DME, Diabetic Macular Edema, NVAMD, Neovascular Age-related Macular Degeneration, BRVO, Branch Retinal Vein Occlusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- EyeBiotech Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYE201Also: Tiespectus, MK-8748EYE201 solution for intravitreal administration | Drug | 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 |
Primary outcome
Adverse Events
Time frame: 12 Weeks
1 secondary outcome
Best- Corrected Visual Acuity
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EYE201 in people with Diabetic Macular Edema (DME) and Neovascular Age-related Macular Degeneration (NVAMD), run by EyeBiotech Ltd. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.