EYE103 for Diabetic Eye Conditions

(AMARONE Trial)

No longer recruiting at 30 trial locations

Overseen By Keith Baker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EyeBiotech Ltd.

Disqualifiers: Pregnancy, Breastfeeding, Recent eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, EYE103, for diabetic eye conditions. The goal is to assess the safety and effectiveness of EYE103 for individuals with diabetic macular edema (DME) alone or with neovascular age-related macular degeneration (NVAMD) when combined with another treatment. In the first part, researchers will test different doses of EYE103 for safety, while the second part will compare the effectiveness of two selected doses. The trial seeks participants with DME or NVAMD and vision loss, whether untreated or previously treated. As a Phase 1, Phase 2 trial, this research aims to understand how EYE103 works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in eye treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a DME patient, you must not have received any prior treatment for your condition.

Is there any evidence suggesting that EYE103 is likely to be safe for humans?

Research shows that EYE103 is a new treatment under testing for diabetic eye conditions. Although detailed safety information from past studies is limited, EYE103's progression to this stage in clinical trials suggests it demonstrated some safety in earlier research. In early phases, like Phase 1 and 2, researchers assess the treatment's safety for people.

In earlier studies with similar treatments, researchers closely monitored how well patients tolerated different doses and checked for any side effects or reactions. This process is occurring in the current trial as well. They gradually increase doses to observe the body's response.

While specific results from these studies are not available, reaching this point indicates an acceptable safety level so far. Prospective trial participants should know that these safety checks are ongoing, and monitoring remains a key part of the research. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for diabetic eye conditions?

Researchers are excited about EYE103 because it offers a fresh approach to treating diabetic eye conditions. Unlike traditional treatments, which often involve anti-VEGF injections like ranibizumab or aflibercept, EYE103 targets different pathways, potentially reducing inflammation and improving blood flow in the retina. This unique mechanism of action could offer enhanced protection against vision loss and might even work for patients who don't respond well to existing therapies. Additionally, EYE103 is being tested in various doses and combinations to see how it can best help both new and experienced patients, which could lead to more personalized and effective care.

What evidence suggests that EYE103 might be an effective treatment for diabetic eye conditions?

Research shows that EYE103 may help treat diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). In earlier studies, patients with these eye conditions tolerated EYE103 well. This trial will explore various dosages of EYE103 for these conditions. The treatment functions as a special antibody targeting specific pathways involved in these diseases. Early results from the AMARONE trial were positive, suggesting EYE103 could improve vision problems related to these conditions. This makes it a promising option for managing eye health in affected individuals. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion 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 have wet AMD and may or may not have had prior treatments, but I've lost vision in the study eye.

I have vision loss in one eye due to diabetic macular edema.

Exclusion Criteria

I had cataract or glaucoma surgery less than 3 months ago.

I had a YAG laser eye procedure within the last 2 months.

I do not have any conditions that could interfere with the study's assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple Ascending Dose (MAD) Safety Study

The safety of EYE103 is assessed at escalating doses in approximately 12 participants

3 months

Dose-finding Comparative Safety and Efficacy Study

Two doses of EYE103 are selected and their effectiveness is compared in approximately 80 participants

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EYE103

Trial Overview 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.

How Is the Trial Designed?

Group I: Naïve NVAMD Medium Dose Experimental Treatment 1 Intervention

Part 2 Naïve NVAMD combination therapy Medium Dose

Group II: Naïve NVAMD High Dose Experimental Treatment 1 Intervention

Part 2 Naïve NVAMD combination therapy High Dose

Group III: Experienced NVAMD Medium Dose Experimental Treatment 1 Intervention

Part 2 Experienced NVAMD combination therapy Medium Dose

Group IV: Experienced NVAMD High Dose Experimental Treatment 1 Intervention

Part 2 Experienced NVAMD combination therapy High Dose

Group V: Dose 4 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 4 - High Dose

Group VI: Dose 3 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 3 - Mid-High Dose

Group VII: Dose 2 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 2 - Low-Mid Dose

Group VIII: Dose 1 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 1 - Low Dose

Group IX: DME Medium Dose Experimental Treatment 1 Intervention

Part 2 Naïve DME monotherapy Medium Dose

Group X: DME High Dose Experimental Treatment 1 Intervention

Part 2 Naïve DME monotherapy High Dose

Who Is Running the Clinical Trial?

EyeBiotech Ltd.

Lead Sponsor

Trials

3

Recruited

1,100+

Citations

1. merck.com merck.com/news/merck-and-eyebio-announce-initiation-of-phase-2b-3-clinical-trial-for-restoret-for-the-treatment-of-diabetic-macular-edema/

Merck and EyeBio Announce Initiation of Phase 2b/3 ... Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality ...

2. ophthalmologytimes.com ophthalmologytimes.com/view/eyebio-announces-positive-data-from-first-in-human-ph1b-2a-amarone-trial-of-restoret-for-dme-dvamd

EyeBio announces positive data from first-in-human Ph1b ... Twelve-week data from the Ph1b/2a AMARONE trial reveals Restoret to be well-tolerated in patients with diabetic macular edema and neovascular age-related ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06571045

NCT06571045 | A Study to Evaluate the Efficacy and ... EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05919693

NCT05919693 | A 2-part Study Consisting of Multiple ... 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 ...

5. msd.com msd.com/news/msd-and-eyebio-announce-initiation-of-phase-2b-3-clinical-trial-for-restoret-for-the-treatment-of-diabetic-macular-edema/

MSD and EyeBio Announce Initiation of Phase 2b/3 ... Diabetic macular edema (DME) is a serious retinal condition that poses a risk to vision, potentially leading to blindness and a reduced quality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11733175/

Exploring new horizons in neovascular age-related macular ... Neovascular age-related macular degeneration (nAMD) can lead to significant vision impairment through the growth of abnormal neovascular membranes in the ...

7. tnretina.com tnretina.com/research/non-enrolling-studies

Ongoing Clinical Trials 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 ...