AMARONE: 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)

Sponsor

EyeBiotech Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05919693

Collaborator

(none)

Enrollment

Locations

Arms

18.7

Anticipated Duration (Months)

18.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration (NVAMD) Diabetic Macular Edema (DME)	Drug: EYE103	Phase 1/Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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.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 (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Participant Care Provider Outcomes Assessor

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 Part 1 MAD Portion Dose 1 - Low Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Dose 2 Part 1 MAD Portion Dose 2 - Low-Mid Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Dose 3 Part 1 MAD Portion Dose 3 - Mid-High Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Dose 4 Part 1 MAD Portion Dose 4 - High Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: DME Medium Dose Part 2 Naïve DME monotherapy Medium Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: DME High Dose Part 2 Naïve DME monotherapy High Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Naïve NVAMD Medium Dose Part 2 Naïve NVAMD combination therapy Medium Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Naïve NVAMD High Dose Part 2 Naïve NVAMD combination therapy High Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Experienced NVAMD Medium Dose Part 2 Experienced NVAMD combination therapy Medium Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration
Experimental: Experienced NVAMD High Dose Part 2 Experienced NVAMD combination therapy High Dose	Drug: EYE103 EYE103 is a humanized antibody formulated for IVT administration

Outcome Measures

Primary Outcome Measures

Adverse Events [3 months]
Adverse Events

Secondary Outcome Measures

Best-corrected Visual Acuity [3 months]
Best-corrected Visual Acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix, AZ	Phoenix	Arizona	United States	85032
2	Lemont, NV	Lemont	Illinois	United States	60439
3	Reno, NV	Reno	Nevada	United States	89502
4	Germantown, TN	Germantown	Tennessee	United States	38138
5	Amarillo, TX	Amarillo	Texas	United States	79109