ClinicalTrials.gov
History of Changes for Study: NCT05919693
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)
Latest version (submitted December 5, 2023) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 14, 2023 None (earliest Version on record)
2 July 10, 2023 Contacts/Locations and Study Status
3 August 9, 2023 Contacts/Locations and Study Status
4 October 16, 2023 Contacts/Locations and Study Status
5 November 3, 2023 Contacts/Locations and Study Status
6 December 5, 2023 Contacts/Locations and Study Status
Comparison Format:
Scroll up to access the controls
Study NCT05919693
Submitted Date:  June 14, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: EYE103-101
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) (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)
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023
Overall Status: Recruiting
Study Start: June 12, 2023
Primary Completion: December 31, 2024 [Anticipated]
Study Completion: December 31, 2024 [Anticipated]
First Submitted: June 14, 2023
First Submitted that
Met QC Criteria:		 June 14, 2023
First Posted: June 26, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 14, 2023
Last Update Posted: June 26, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: EyeBiotech Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
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)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment

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.
Number of Arms: 10
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Allocation: Randomized
Enrollment: 92 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Adverse Events
[ Time Frame: 3 months ]

Adverse Events
Secondary Outcome Measures:
1. Best-corrected Visual Acuity
[ Time Frame: 3 months ]

Best-corrected Visual Acuity
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Keith Baker, MD
Telephone: 212-914-0127
Email: ClinicalInquiries@eyebiotech.com
Locations: United States, Arizona
Phoenix, AZ
[Recruiting]
Phoenix, Arizona, United States, 85032
Contact:Contact: Keith Baker Baker 212-914-0127 ClinicalInquiries@eyebiotech.com
United States, Illinois
Lemont, NV
[Recruiting]
Lemont, Illinois, United States, 60439
Contact:Contact: Keith Baker 212-914-0127 ClinicalInquiries@eyebiotech.com
United States, Nevada
Reno, NV
[Recruiting]
Reno, Nevada, United States, 89502
Contact:Contact: Keith Baker 212-914-0127 ClinicalInquiries@eyebiotech.com
United States, Tennessee
Germantown, TN
[Recruiting]
Germantown, Tennessee, United States, 38138
Contact:Contact: Keith Baker 212-914-0127 ClinicalInquiries@eyebiotech.com
United States, Texas
Amarillo, TX
[Recruiting]
Amarillo, Texas, United States, 79109
Contact:Contact: Keith Baker 212-914-0127 ClinicalInquiries@eyebiotech.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services