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)

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

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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