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)
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| ClinicalTrials.gov Identifier: NCT05919693 |
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Recruitment Status :
Recruiting
First Posted : June 26, 2023
Last Update Posted : December 7, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neovascular Age-related Macular Degeneration (NVAMD) Diabetic Macular Edema (DME) | Drug: EYE103 | Phase 1 Phase 2 |
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 (Clinical Trial) |
| Estimated Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention 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 (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | Participant Care Provider Outcomes Assessor |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | June 12, 2023 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dose 1
Part 1 MAD Portion Dose 1 - Low Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Dose 2
Part 1 MAD Portion Dose 2 - Low-Mid Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Dose 3
Part 1 MAD Portion Dose 3 - Mid-High Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Dose 4
Part 1 MAD Portion Dose 4 - High Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: DME Medium Dose
Part 2 Naïve DME monotherapy Medium Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: DME High Dose
Part 2 Naïve DME monotherapy High Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Naïve NVAMD Medium Dose
Part 2 Naïve NVAMD combination therapy Medium Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Naïve NVAMD High Dose
Part 2 Naïve NVAMD combination therapy High Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Experienced NVAMD Medium Dose
Part 2 Experienced NVAMD combination therapy Medium Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
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Experimental: Experienced NVAMD High Dose
Part 2 Experienced NVAMD combination therapy High Dose
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Drug: EYE103
EYE103 is a humanized antibody formulated for IVT administration |
- Adverse Events [ Time Frame: 3 months ]Adverse Events
- Best-corrected Visual Acuity [ Time Frame: 3 months ]Best-corrected Visual Acuity
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919693
| Contact: Keith Baker, MD | 212-914-0127 | ClinicalInquiries@eyebiotech.com |
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| Responsible Party: | EyeBiotech Ltd. |
| ClinicalTrials.gov Identifier: | NCT05919693 |
| Other Study ID Numbers: |
EYE103-101 |
| First Posted: | June 26, 2023 Key Record Dates |
| Last Update Posted: | December 7, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neovascular Age-related Macular Degeneration (NVAMD) Diabetic Macular Edema (DME) Age-related Macular Degeneration (AMD) |
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Macular Degeneration Macular Edema Wet Macular Degeneration Edema |
Retinal Degeneration Retinal Diseases Eye Diseases |