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Trial record 1 of 2 for:    amarone
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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)

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ClinicalTrials.gov Identifier: NCT05919693
Recruitment Status : Recruiting
First Posted : June 26, 2023
Last Update Posted : December 7, 2023
Sponsor:
Information provided by (Responsible Party):
EyeBiotech Ltd.

Tracking Information
First Submitted Date  ICMJE June 14, 2023
First Posted Date  ICMJE June 26, 2023
Last Update Posted Date December 7, 2023
Actual Study Start Date  ICMJE June 12, 2023
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2023)		 Adverse Events [ Time Frame: 3 months ]
Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2023)		 Best-corrected Visual Acuity [ Time Frame: 3 months ]
Best-corrected Visual Acuity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Participant Care Provider Outcomes Assessor
Primary Purpose: Treatment
Condition  ICMJE
  • Neovascular Age-related Macular Degeneration (NVAMD)
  • Diabetic Macular Edema (DME)
Intervention  ICMJE Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration
Study Arms  ICMJE
  • Experimental: Dose 1
    Part 1 MAD Portion Dose 1 - Low Dose
    Intervention: Drug: EYE103
  • Experimental: Dose 2
    Part 1 MAD Portion Dose 2 - Low-Mid Dose
    Intervention: Drug: EYE103
  • Experimental: Dose 3
    Part 1 MAD Portion Dose 3 - Mid-High Dose
    Intervention: Drug: EYE103
  • Experimental: Dose 4
    Part 1 MAD Portion Dose 4 - High Dose
    Intervention: Drug: EYE103
  • Experimental: DME Medium Dose
    Part 2 Naïve DME monotherapy Medium Dose
    Intervention: Drug: EYE103
  • Experimental: DME High Dose
    Part 2 Naïve DME monotherapy High Dose
    Intervention: Drug: EYE103
  • Experimental: Naïve NVAMD Medium Dose
    Part 2 Naïve NVAMD combination therapy Medium Dose
    Intervention: Drug: EYE103
  • Experimental: Naïve NVAMD High Dose
    Part 2 Naïve NVAMD combination therapy High Dose
    Intervention: Drug: EYE103
  • Experimental: Experienced NVAMD Medium Dose
    Part 2 Experienced NVAMD combination therapy Medium Dose
    Intervention: Drug: EYE103
  • Experimental: Experienced NVAMD High Dose
    Part 2 Experienced NVAMD combination therapy High Dose
    Intervention: Drug: EYE103
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2023)		 92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Keith Baker, MD 212-914-0127 ClinicalInquiries@eyebiotech.com
Listed Location Countries  ICMJE Argentina,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05919693
Other Study ID Numbers  ICMJE EYE103-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party EyeBiotech Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE EyeBiotech Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EyeBiotech Ltd.
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP