A 2-part Study Consisting of Multiple Ascending Dose (MAD... | NCT05919693

Studies
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

Sponsor

EyeBiotech Ltd.

Status

Completed

Last Update Posted

Nov 20, 2025Actual

Enrollment

33Actual

Phase

Phase 1Phase 2

Conditions

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

Interventions

EYE103

Countries

United States
Argentina
Puerto Rico
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
MK-3000-003	Other Identifier	Merck

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)

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2023Actual

Primary Completion Date

Aug 26, 2024Actual

Completion Date

Aug 26, 2024Actual

First Submitted Date

Jun 14, 2023

First Submission Date that Met QC Criteria

Jun 14, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 26, 2024

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Dec 7, 2023Actual

Last Update Submitted Date

Nov 18, 2025

Last Update Posted Date

Nov 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EYE103	Drug	EYE103 is a humanized antibody formulated for IVT administration	DME High Dose DME Medium Dose Dose 1 Dose 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Adverse Events	3 months

Secondary Outcomes

Measure	Description	Time Frame
Best-corrected Visual Acuity	Best-corrected Visual Acuity	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix, AZ		Phoenix	Arizona	85032	United States
Bakersfield, CA

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Intervention 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.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases