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Neovascular Age-related Macular Degeneration (NVAMD)Phase 1/2AMARONENCT05919693

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)

A Phase 1/2 study testing EYE103 in people with Neovascular Age-related Macular Degeneration (NVAMD) and Diabetic Macular Edema (DME), run by EyeBiotech Ltd. at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
EYE103
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
32 sitesin 4 countries
Study dates
12 Jun 2023to 26 Aug 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  • DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age
  • Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.
  • DME patients must have vision loss in the study eye
  • NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye

Who cannot join

  • Be pregnant or breastfeeding
  • History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening
  • Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening
  • Any other condition except for DME or NVAMD or that could affect interpretation of study assessments

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States27 sites

  • Abilene, TX

    Abilene, Texas, 79606

  • Amarillo, TX

    Amarillo, Texas, 79109

  • Austin, TX

    Austin, Texas, 78705

  • Bakersfield, CA

    Bakersfield, California, 93309

  • Bellaire, TX

    Bellaire, Texas, 77401

  • Colorado Springs, Colorado

    Colorado Springs, Colorado, 80909

  • Dallas, TX

    Dallas, Texas, 75231

  • Germantown, TN

    Germantown, Tennessee, 38138

  • Hagerstown, MD

    Hagerstown, Maryland, 21740

  • Katy, TX

    Katy, Texas, 77494

  • Knoxville, TN

    Knoxville, Tennessee, 37922

  • Lakewood, CO

    Lakewood, Colorado, 80288

  • Lemont, NV

    Lemont, Illinois, 60439

  • McAllen, TX

    McAllen, Texas, 78503

  • Modesto, CA

    Modesto, California, 95356

  • Mountain View, CA

    Mountain View, California, 94040

  • Nashville, TN

    Nashville, Tennessee, 37203

  • Phoenix, AZ

    Phoenix, Arizona, 85032

  • Plano, TX

    Plano, Texas, 75075

  • Pompano Beach

    Pompano Beach, Florida, 33064

  • Reno, NV

    Reno, Nevada, 89502

  • Round Rock, TX

    Round Rock, Texas, 78681

  • Sacramento, CA

    Sacramento, California, 95825

  • Sacramento, CA

    Sacramento, California, 95841

  • San Antonio, TX

    San Antonio, Texas, 78240

  • The Woodlands, TX

    The Woodlands, Texas, 77384

  • West Columbia, SC

    West Columbia, South Carolina, 29169

Other trials in United States

Argentina2 sites

  • Caba, Argentina

    Caba, 1023

  • Ciudad Autonoma Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1121ABB

Other trials in Argentina

United Kingdom2 sites

  • London, England

    London, England, NW10 7NS

  • London, UK

    London, W1G7LB

Other trials in United Kingdom

Puerto Rico1 site

  • Arecibo, PR

    Arecibo, PR, 00612

Other trials in Puerto Rico

About this study

Official title: A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Read the detailed description

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Being tested
EYE103
Keywords
Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME), Age-related Macular Degeneration (AMD)
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EYE103Drug

    EYE103 is a humanized antibody formulated for IVT administration

Study groups in NCT05919693
Study groupRoleWhat they receive
Dose 1ExperimentalPart 1 MAD Portion Dose 1 - Low Dose
Receives: Drug: EYE103
Dose 2ExperimentalPart 1 MAD Portion Dose 2 - Low-Mid Dose
Receives: Drug: EYE103
Dose 3ExperimentalPart 1 MAD Portion Dose 3 - Mid-High Dose
Receives: Drug: EYE103
Dose 4ExperimentalPart 1 MAD Portion Dose 4 - High Dose
Receives: Drug: EYE103
DME Medium DoseExperimentalPart 2 Naïve DME monotherapy Medium Dose
Receives: Drug: EYE103
DME High DoseExperimentalPart 2 Naïve DME monotherapy High Dose
Receives: Drug: EYE103
Naïve NVAMD Medium DoseExperimentalPart 2 Naïve NVAMD combination therapy Medium Dose
Receives: Drug: EYE103
Naïve NVAMD High DoseExperimentalPart 2 Naïve NVAMD combination therapy High Dose
Receives: Drug: EYE103
Experienced NVAMD Medium DoseExperimentalPart 2 Experienced NVAMD combination therapy Medium Dose
Receives: Drug: EYE103
Experienced NVAMD High DoseExperimentalPart 2 Experienced NVAMD combination therapy High Dose
Receives: Drug: EYE103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

    Systemic DLTs are defined as a Grade III (severe), IV (life threatening) or V (death related to adverse event) toxicities as defined in the National Cancer Institute (NCI) Common Toxicity Criteria, or any significant severe toxicity deemed related to study drug by the principal investigator. Ocular DLTs are defined as: loss of 4 or more lines of visual acuity, clinically significant inflammation, increase of intra-ocular pressure (IOP) from baseline of > or =15 mmHg, accelerated formation of cataract, other severe ocular abnormalities not usually seen in subjects with the condition under study, or significant retinal or choroidal vascular abnormalities seen on fluorescein angiogram deemed related to study drug by the investigator.

    Measured: Up to approximately 12 weeks

  2. Number of Participants Who Experienced an Adverse Event (AE)

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Up to approximately 12 weeks

  3. Number of Participants Who Experienced a Serious Adverse Event (SAE)

    An SAE is defined as any adverse experience occurring at any dose that results in any of the following outcomes: Results in death; Is life threatening (immediate risk of death); results in persistent or significant disability/incapacity; requires participant hospitalization or prolongs participant hospitalization; or results in a congenital anomaly/birth defect in a neonate/infant

    Measured: Up to approximately 24 weeks

  4. Number of Participants Who Experienced Clinically Meaningful Changes in Laboratory Assessments

    Clinical laboratory tests, including overnight fasting serum chemistry, lipid panel, hematology, and coagulation panel were collected at baseline and at week 12 study visit. Any laboratory test result considered by the investigator to be clinically significant was considered to be an AE. Clinically significant abnormal values were followed up until repeat test results return to normal, stabilize, or are no longer clinically significant.

    Measured: Baseline and Week 12

  5. Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) to Week 12 in the Study Eye - DME Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to week 12 is presented.

    Measured: Baseline and Week 12

  6. Mean Change From Baseline in BCVA to Week 12 in the Study Eye -NVAMD Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. Mean change in ETDRS letters from baseline to week 12 is presented.

    Measured: Baseline and Week 12

Secondary outcomes (8)

  1. Number of Participants With ETDRS BCVA Response- Treatment-Naive DME Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The number of participants who gained 15 or more letters as measured by ETDRS from baseline in the study eye is presented.

    Measured: Baseline and Week 12

  2. Number of Participants With ETDRS BCVA Response- Treatment-Naive NVAMD Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The number of participants who gained 15 or more letters as measured by ETDRS from baseline in the study eye is presented.

    Measured: Baseline and Week 12

  3. Mean Change in Retinal Central Subfield Thickness (CST) From Baseline in the Study Eye on Spectral Domain Optical Coherence Tomography (SDOCT): Treatment-naive DME Participants

    SDOCT machines and technicians were certified at each study site by the independent reading center (IRC) prior to study start. Images were sent to the IRC for assessment. A negative change (decrease) in retinal CST from baseline indicates a decrease in retinal thickness or swelling and is considered a better outcome than no change or an increase in CST. The mean change at 12 weeks in the study eye for retinal CST from baseline is presented.

    Measured: Baseline and 12 weeks

  4. Mean Change in Retinal CST From Baseline in the Study Eye on SDOCT: Treatment-naive NVAMD Participants

    SDOCT machines and technicians were certified at each study site by the independent reading center (IRC) prior to study start. Images were sent to the IRC for assessment. A negative change (decrease) in retinal CST from baseline indicates a decrease in retinal thickness or swelling and is considered a better outcome than no change or an increase in CST. The mean change at 12 weeks in the study eye for retinal CST from baseline is presented.

    Measured: Baseline and 12 weeks

  5. Number of Participants With Loss of Vision From Baseline by 15 or More Letters at Week 12-Treatment Naive DME Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The number of participants who lost 15 or more letters as measured by ETDRS from baseline in the study eye is presented.

    Measured: Baseline and Week 12

  6. Number of Participants With Loss of Vision From Baseline by 15 or More Letters at Week 12-Treatment Naive NVAMD Participants

    Participants' BCVA in the study eye is measured using the Early Treatment of Diabetic Retinopathy (ETDRS) methodology. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity. The number of participants who lost 15 or more letters as measured by ETDRS from baseline in the study eye is presented.

    Measured: Baseline and Week 12

  7. Percent Change in Excess Retinal Fluid From Baseline at Week 12: Treatment-naive DME Participants

    Retinal fluid in the study eye was measured by central subfield thickness (CST) as evaluated on SDOCT. SDOCT machines and technicians were certified at each study site by the independent reading center (IRC) prior to study start. Images were sent to the IRC for assessment. This outcome measure evaluates the relative change in excess CST above > 300 um from baseline to Week 12, expressed as a percentage of the baseline value. The percent change from baseline in CST in the study eye is calculated as follows: (Excess CST Baseline-Excess CST Week 12/Excess CST Baseline) *100. Positive values represent a percent reduction in excess retinal fluid (clinical improvement), and negative values represent a percent increase in excess retinal fluid (clinical worsening).

    Measured: Baseline and Week 12

  8. Percent Change in Excess Retinal Fluid From Baseline at Week 12: Treatment-naive NVAMD Participants

    Retinal fluid in the study eye was measured by central subfield thickness (CST) as evaluated on SDOCT. SDOCT machines and technicians were certified at each study site by the independent reading center (IRC) prior to study start. Images were sent to the IRC for assessment. This outcome measure evaluates the relative change in excess CST above > 300 um from baseline to Week 12, expressed as a percentage of the baseline value. The percent change from baseline in CST in the study eye is calculated as follows: (Excess CST Baseline-Excess CST Week 12/Excess CST Baseline) *100. Positive values represent a percent reduction in excess retinal fluid (clinical improvement), and negative values represent a percent increase in excess retinal fluid (clinical worsening).

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start12 Jun 2023
  3. Primary completion26 Aug 2024
  4. Study completion26 Aug 2024

Resources

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-dose escalation 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 randomized single-masked study where patients on all arms will be enrolled in parallel.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919693
Sponsor's protocol ID
EYE103-101
Other IDs
MK-3000-003
Acronym
AMARONE
Status last verified
Sep 2026
First submitted
14 Jun 2023
Last updated
29 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EYE103 in people with Neovascular Age-related Macular Degeneration (NVAMD) and Diabetic Macular Edema (DME), run by EyeBiotech Ltd. at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Argentina, United Kingdom, 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?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) (time frame: Up to approximately 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919693.

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 29 Sep 2026.

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