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)

Diabetic Macular Edema (DME) Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05919693
• Other study ID #: EYE103-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: EyeBiotech Ltd.
• Contact: Keith Baker, MD
• Phone: 212-914-0127
• Email: ClinicalInquiries[@]eyebiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Degeneration
• Macular Edema
• Wet Macular Degeneration

Intervention

Drug:
• EYE103
EYE103 is a humanized antibody formulated for IVT administration

Locations

Country	Name	City	State
Argentina	Caba, Argentina	Caba
Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma de Buenos Aires	Buenos Aires
Puerto Rico	Arecibo, PR	Arecibo
United Kingdom	London, England	London	England
United Kingdom	London, UK	London
United States	Abilene, TX	Abilene	Texas
United States	Amarillo, TX	Amarillo	Texas
United States	Austin, TX	Austin	Texas
United States	Bakersfield, CA	Bakersfield	California
United States	Bellaire, TX	Bellaire	Texas
United States	Colorado Springs, Colorado	Colorado Springs	Colorado
United States	Dallas, TX	Dallas	Texas
United States	Germantown, TN	Germantown	Tennessee
United States	Hagerstown, MD	Hagerstown	Maryland
United States	Katy, TX	Katy	Texas
United States	Knoxville, TN	Knoxville	Tennessee
United States	Lakewood, CO	Lakewood	Colorado
United States	Lemont, NV	Lemont	Illinois
United States	McAllen, TX	McAllen	Texas
United States	Modesto, CA	Modesto	California
United States	Mountain View, CA	Mountain View	California
United States	Nashville, TN	Nashville	Tennessee
United States	Phoenix, AZ	Phoenix	Arizona
United States	Plano, TX	Plano	Texas
United States	Pompano Beach	Pompano Beach	Florida
United States	Reno, NV	Reno	Nevada
United States	Round Rock, TX	Round Rock	Texas
United States	Sacramento, CA	Sacramento	California
United States	Sacramento, CA	Sacramento	California
United States	San Antonio, TX	San Antonio	Texas
United States	The Woodlands, TX	The Woodlands	Texas
United States	West Columbia, SC	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
EyeBiotech Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse Events	3 months
Secondary	Best-corrected Visual Acuity	Best-corrected Visual Acuity	3 months