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Monoclonal Antibodies
EYE103 for Diabetic Eye Conditions (AMARONE Trial)
Phase 1 & 2
Recruiting
Research Sponsored by EyeBiotech Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
AMARONE Trial Summary
This trial tests a potential drug to help people with vision problems caused by diabetes or macular degeneration. It will assess its safety and effectiveness.
Who is the study for?
This trial is for adults with diabetic macular edema (DME) who are at least 18 years old and have not been treated before, or those with neovascular age-related macular degeneration (NVAMD) who are 50 or older. Participants must understand the study, agree to its procedures, and have vision loss in the affected eye.Check my eligibility
What is being tested?
The study tests EYE103's safety and effectiveness for DME as a single treatment and NVAMD in combination with anti-VEGF. It has two parts: first, escalating doses to check safety; second, comparing two selected doses to see which works better.See study design
What are the potential side effects?
While specific side effects of EYE103 aren't listed here, similar treatments may cause eye irritation or discomfort, increased eye pressure, bleeding inside the eye, cataract formation or worsening of existing cataracts.
AMARONE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Best-corrected Visual Acuity
AMARONE Trial Design
10Treatment groups
Experimental Treatment
Group I: Naïve NVAMD Medium DoseExperimental Treatment1 Intervention
Part 2 Naïve NVAMD combination therapy Medium Dose
Group II: Naïve NVAMD High DoseExperimental Treatment1 Intervention
Part 2 Naïve NVAMD combination therapy High Dose
Group III: Experienced NVAMD Medium DoseExperimental Treatment1 Intervention
Part 2 Experienced NVAMD combination therapy Medium Dose
Group IV: Experienced NVAMD High DoseExperimental Treatment1 Intervention
Part 2 Experienced NVAMD combination therapy High Dose
Group V: Dose 4Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 4 - High Dose
Group VI: Dose 3Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 3 - Mid-High Dose
Group VII: Dose 2Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 2 - Low-Mid Dose
Group VIII: Dose 1Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 1 - Low Dose
Group IX: DME Medium DoseExperimental Treatment1 Intervention
Part 2 Naïve DME monotherapy Medium Dose
Group X: DME High DoseExperimental Treatment1 Intervention
Part 2 Naïve DME monotherapy High Dose
Find a Location
Who is running the clinical trial?
EyeBiotech Ltd.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with DME and have not received any treatments, or I have NVAMD and may or may not have received treatments.I had cataract or glaucoma surgery less than 3 months ago.I had a YAG laser eye procedure within the last 2 months.I am over 18 with DME or over 50 with NVAMD.I do not have any conditions that could interfere with the study's assessments.I understand the study and its risks and am willing to sign consent.I have vision loss in one eye due to diabetic macular edema.I have wet AMD and may or may not have had prior treatments, but I've lost vision in the study eye.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 1
- Group 2: Dose 2
- Group 3: Dose 3
- Group 4: Dose 4
- Group 5: DME Medium Dose
- Group 6: DME High Dose
- Group 7: Naïve NVAMD Medium Dose
- Group 8: Naïve NVAMD High Dose
- Group 9: Experienced NVAMD Medium Dose
- Group 10: Experienced NVAMD High Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for participants in this trial?
"The trial's profile on clinicaltrials.gov affirms that enrolment is still open; the study was initially posted June 12th 2023 and its most recent update occurred two days later, on June 14th of the same year."
Answered by AI
How far-reaching is the availability of this trial?
"This study is currently recruiting patients at 5 distinct sites, such as Lemont in Nevada and Reno in Nevada. Additionally, Germantown located in Tennessee serves as another recruitment centre, with a further five locations also participating."
Answered by AI
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