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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Drug: EYE103


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>Part 1 MAD Portion Dose 1 - Low Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Dose 2<br>Part 1 MAD Portion Dose 2 - Low-Mid Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Dose 3<br>Part 1 MAD Portion Dose 3 - Mid-High Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Dose 4<br>Part 1 MAD Portion Dose 4 - High Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: DME Medium Dose<br>Part 2 Naïve DME monotherapy Medium Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: DME High Dose<br>Part 2 Naïve DME monotherapy High Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Naïve NVAMD Medium Dose<br>Part 2 Naïve NVAMD combination therapy Medium Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Naïve NVAMD High Dose<br>Part 2 Naïve NVAMD combination therapy High Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Experienced NVAMD Medium Dose<br>Part 2 Experienced NVAMD combination therapy Medium Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|
| Experimental: Experienced NVAMD High Dose<br>Part 2 Experienced NVAMD combination therapy High Dose | Drug: EYE103<br>* EYE103 is a humanized antibody formulated for IVT administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Events | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME), Age-related Macular Degeneration (AMD)