The trial is taking place at:
E

El Camino Health - Clinical Research Department | Mountain View, CA

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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)

E

EyeBiotech

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

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

Treatments

Drug: EYE103

Study type

Interventional

Funder types

Industry

Identifiers

NCT05919693
EYE103-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

92 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

92 participants in 10 patient groups

Dose 1
Experimental group
Description:
Part 1 MAD Portion Dose 1 - Low Dose
Treatment:
Drug: EYE103
Dose 2
Experimental group
Description:
Part 1 MAD Portion Dose 2 - Low-Mid Dose
Treatment:
Drug: EYE103
Dose 3
Experimental group
Description:
Part 1 MAD Portion Dose 3 - Mid-High Dose
Treatment:
Drug: EYE103
Dose 4
Experimental group
Description:
Part 1 MAD Portion Dose 4 - High Dose
Treatment:
Drug: EYE103
DME Medium Dose
Experimental group
Description:
Part 2 Naïve DME monotherapy Medium Dose
Treatment:
Drug: EYE103
DME High Dose
Experimental group
Description:
Part 2 Naïve DME monotherapy High Dose
Treatment:
Drug: EYE103
Naïve NVAMD Medium Dose
Experimental group
Description:
Part 2 Naïve NVAMD combination therapy Medium Dose
Treatment:
Drug: EYE103
Naïve NVAMD High Dose
Experimental group
Description:
Part 2 Naïve NVAMD combination therapy High Dose
Treatment:
Drug: EYE103
Experienced NVAMD Medium Dose
Experimental group
Description:
Part 2 Experienced NVAMD combination therapy Medium Dose
Treatment:
Drug: EYE103
Experienced NVAMD High Dose
Experimental group
Description:
Part 2 Experienced NVAMD combination therapy High Dose
Treatment:
Drug: EYE103

Trial contacts and locations

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Central trial contact

Keith Baker, MD

Data sourced from clinicaltrials.gov

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