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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) (AMARONE)

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EYE103
Sponsored by
EyeBiotech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (NVAMD) focused on measuring Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME), Age-related Macular Degeneration (AMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Phoenix, AZRecruiting
  • Modesto, CARecruiting
  • Mountain View, CARecruiting
  • Sacramento, CARecruiting
  • Sacramento, CARecruiting
  • Lakewood, CORecruiting
  • Pompano BeachRecruiting
  • Lemont, NVRecruiting
  • Hagerstown, MDRecruiting
  • Reno, NVRecruiting
  • West Columbia, SCRecruiting
  • Germantown, TNRecruiting
  • Knoxville, TNRecruiting
  • Nashville, TNRecruiting
  • Abilene, TXRecruiting
  • Amarillo, TXRecruiting
  • Austin, TXRecruiting
  • Bellaire, TXRecruiting
  • Katy, TXRecruiting
  • McAllen, TXRecruiting
  • Round Rock, TXRecruiting
  • San Antonio, TXRecruiting
  • The Woodlands, TXRecruiting
  • Ciudad Autonoma Buenos AiresRecruiting
  • Arecibo, PRRecruiting
  • London, UKRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Dose 4

DME Medium Dose

DME High Dose

Naïve NVAMD Medium Dose

Naïve NVAMD High Dose

Experienced NVAMD Medium Dose

Experienced NVAMD High Dose

Arm Description

Part 1 MAD Portion Dose 1 - Low Dose

Part 1 MAD Portion Dose 2 - Low-Mid Dose

Part 1 MAD Portion Dose 3 - Mid-High Dose

Part 1 MAD Portion Dose 4 - High Dose

Part 2 Naïve DME monotherapy Medium Dose

Part 2 Naïve DME monotherapy High Dose

Part 2 Naïve NVAMD combination therapy Medium Dose

Part 2 Naïve NVAMD combination therapy High Dose

Part 2 Experienced NVAMD combination therapy Medium Dose

Part 2 Experienced NVAMD combination therapy High Dose

Outcomes

Primary Outcome Measures

Adverse Events
Adverse Events

Secondary Outcome Measures

Best-corrected Visual Acuity
Best-corrected Visual Acuity

Full Information

First Posted
June 14, 2023
Last Updated
October 16, 2023
Sponsor
EyeBiotech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05919693
Brief Title
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)
Acronym
AMARONE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyeBiotech Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participant Care Provider Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
Part 1 MAD Portion Dose 1 - Low Dose
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
Part 1 MAD Portion Dose 2 - Low-Mid Dose
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
Part 1 MAD Portion Dose 3 - Mid-High Dose
Arm Title
Dose 4
Arm Type
Experimental
Arm Description
Part 1 MAD Portion Dose 4 - High Dose
Arm Title
DME Medium Dose
Arm Type
Experimental
Arm Description
Part 2 Naïve DME monotherapy Medium Dose
Arm Title
DME High Dose
Arm Type
Experimental
Arm Description
Part 2 Naïve DME monotherapy High Dose
Arm Title
Naïve NVAMD Medium Dose
Arm Type
Experimental
Arm Description
Part 2 Naïve NVAMD combination therapy Medium Dose
Arm Title
Naïve NVAMD High Dose
Arm Type
Experimental
Arm Description
Part 2 Naïve NVAMD combination therapy High Dose
Arm Title
Experienced NVAMD Medium Dose
Arm Type
Experimental
Arm Description
Part 2 Experienced NVAMD combination therapy Medium Dose
Arm Title
Experienced NVAMD High Dose
Arm Type
Experimental
Arm Description
Part 2 Experienced NVAMD combination therapy High Dose
Intervention Type
Drug
Intervention Name(s)
EYE103
Intervention Description
EYE103 is a humanized antibody formulated for IVT administration
Primary Outcome Measure Information:
Title
Adverse Events
Description
Adverse Events
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Best-corrected Visual Acuity
Description
Best-corrected Visual Acuity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Baker, MD
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Information:
Facility Name
Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Modesto, CA
City
Modesto
State/Province
California
ZIP/Postal Code
95356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Mountain View, CA
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Sacramento, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Sacramento, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Lakewood, CO
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80288
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Pompano Beach
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Lemont, NV
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Hagerstown, MD
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Reno, NV
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
West Columbia, SC
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Germantown, TN
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Knoxville, TN
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Abilene, TX
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Amarillo, TX
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Austin, TX
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Bellaire, TX
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Katy, TX
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
McAllen, TX
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Round Rock, TX
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
The Woodlands, TX
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Ciudad Autonoma Buenos Aires
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1121ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
Arecibo, PR
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com
Facility Name
London, UK
City
London
ZIP/Postal Code
W1G7LB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Baker
Phone
212-914-0127
Email
ClinicalInquiries@eyebiotech.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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