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 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: EYE103-101MK-3000-003
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 32

Brief 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. 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Up to approximately 12 weeks

• 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.

  Up to approximately 12 weeks

• 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

  Up to approximately 24 weeks

• 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.

  Baseline and Week 12

• 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.

  Baseline and Week 12

• 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.

  Baseline and Week 12

Secondary Outcomes (8)

• Number of Participants With ETDRS BCVA Response- Treatment-Naive DME Participants

  Baseline and Week 12

• Number of Participants With ETDRS BCVA Response- Treatment-Naive NVAMD Participants

  Baseline and Week 12

• 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

  Baseline and 12 weeks

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

  Baseline and 12 weeks

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

  Baseline and Week 12

Study Arms (10)

Dose 1

EXPERIMENTAL

Part 1 MAD Portion Dose 1 - Low Dose

Drug: EYE103

Dose 2

EXPERIMENTAL

Part 1 MAD Portion Dose 2 - Low-Mid Dose

Drug: EYE103

Dose 3

EXPERIMENTAL

Part 1 MAD Portion Dose 3 - Mid-High Dose

Drug: EYE103

Dose 4

EXPERIMENTAL

Part 1 MAD Portion Dose 4 - High Dose

Drug: EYE103

DME Medium Dose

EXPERIMENTAL

Part 2 Naïve DME monotherapy Medium Dose

Drug: EYE103

DME High Dose

EXPERIMENTAL

Part 2 Naïve DME monotherapy High Dose

Drug: EYE103

Naïve NVAMD Medium Dose

EXPERIMENTAL

Part 2 Naïve NVAMD combination therapy Medium Dose

Drug: EYE103

Naïve NVAMD High Dose

EXPERIMENTAL

Part 2 Naïve NVAMD combination therapy High Dose

Drug: EYE103

Experienced NVAMD Medium Dose

EXPERIMENTAL

Part 2 Experienced NVAMD combination therapy Medium Dose

Drug: EYE103

Experienced NVAMD High Dose

EXPERIMENTAL

Part 2 Experienced NVAMD combination therapy High Dose

Drug: EYE103

Interventions

EYE103 DRUG

EYE103 is a humanized antibody formulated for IVT administration

DME High Dose; DME Medium Dose; Dose 1; Dose 2; Dose 3; Dose 4; Experienced NVAMD High Dose; Experienced NVAMD Medium Dose; Naïve NVAMD High Dose; Naïve NVAMD Medium Dose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeBiotech Ltd.: lead

Study Sites (32)

Phoenix, AZ

Phoenix, Arizona, 85032, United States

Location

Bakersfield, CA

Bakersfield, California, 93309, United States

Location

Modesto, CA

Modesto, California, 95356, United States

Location

Mountain View, CA

Mountain View, California, 94040, United States

Location

Sacramento, CA

Sacramento, California, 95825, United States

Location

Sacramento, CA

Sacramento, California, 95841, United States

Location

Colorado Springs, Colorado

Colorado Springs, Colorado, 80909, United States

Location

Lakewood, CO

Lakewood, Colorado, 80288, United States

Location

Pompano Beach

Pompano Beach, Florida, 33064, United States

Location

Lemont, NV

Lemont, Illinois, 60439, United States

Location

Hagerstown, MD

Hagerstown, Maryland, 21740, United States

Location

Reno, NV

Reno, Nevada, 89502, United States

Location

West Columbia, SC

West Columbia, South Carolina, 29169, United States

Location

Germantown, TN

Germantown, Tennessee, 38138, United States

Location

Knoxville, TN

Knoxville, Tennessee, 37922, United States

Location

Nashville, TN

Nashville, Tennessee, 37203, United States

Location

Abilene, TX

Abilene, Texas, 79606, United States

Location

Amarillo, TX

Amarillo, Texas, 79109, United States

Location

Austin, TX

Austin, Texas, 78705, United States

Location

Bellaire, TX

Bellaire, Texas, 77401, United States

Location

Dallas, TX

Dallas, Texas, 75231, United States

Location

Katy, TX

Katy, Texas, 77494, United States

Location

McAllen, TX

McAllen, Texas, 78503, United States

Location

Plano, TX

Plano, Texas, 75075, United States

Location

Round Rock, TX

Round Rock, Texas, 78681, United States

Location

San Antonio, TX

San Antonio, Texas, 78240, United States

Location

The Woodlands, TX

The Woodlands, Texas, 77384, United States

Location

Ciudad Autonoma Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1121ABB, Argentina

Location

Caba, Argentina

Caba, 1023, Argentina

Location

Arecibo, PR

Arecibo, PR, 00612, Puerto Rico

Location

London, England

London, England, NW10 7NS, United Kingdom

Location

London, UK

London, W1G7LB, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 26, 2023
• Study Start: June 12, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: September 29, 2026
• Results First Posted: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2); PR (1); GB (2); US (27)