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)

December 5, 2023 updated by: EyeBiotech Ltd.

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3 months
Adverse Events
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeBiotech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYE103-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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