EYE201 for Eye Conditions

Recruiting at 26 trial locations

Overseen By Keith Baker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EyeBiotech Ltd.

Disqualifiers: Pregnancy, Uncontrolled blood pressure, others

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

Compensation: Varies

Number of Visits: 7

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, EYE201, for safety and effectiveness in certain eye conditions. In the first part, participants with branch retinal vein occlusion (BRVO) receive increasing doses to assess safety. The second part compares two doses in individuals with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD) to evaluate effectiveness. Those diagnosed with these conditions and experiencing vision issues may be suitable candidates. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that EYE201 is likely to be safe for humans?

In a previous study, researchers examined the safety of EYE201 for individuals with branch retinal vein occlusion (BRVO) and other eye conditions. They found that EYE201 was generally well-tolerated, with most participants experiencing no serious side effects. Some felt mild discomfort after injections, but these effects were temporary.

For diabetic macular edema (DME) and neovascular macular degeneration (NVAMD), other studies have tested similar treatments that function like EYE201. These studies have shown that these treatments are safe for use in the eye, with most side effects being mild and short-lived.

Since this trial is in the early stages, it primarily focuses on safety. Researchers are carefully monitoring for any side effects as participants receive different doses of the treatment. If EYE201 proves safe in these studies, it could advance to more advanced testing phases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about EYE201 because it offers a novel approach to treating eye conditions like diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Unlike existing treatments that primarily use anti-VEGF injections to slow vision loss, EYE201 may utilize a different mechanism, potentially targeting additional pathways involved in these diseases. This could mean improved effectiveness or fewer side effects, giving patients a new option that could enhance their quality of life.

What evidence suggests that EYE201 might be an effective treatment for eye conditions?

Research has shown that EYE201 is under study for its potential to treat eye conditions such as diabetic macular edema (DME) and neovascular macular degeneration (NVAMD). EYE201 targets specific processes involved in these conditions, which may help reduce swelling and improve vision. Early evidence suggests that treatments for these conditions can prevent vision loss, with some patients even experiencing improvements. This trial will evaluate different dosages of EYE201 for its effectiveness in treating DME and NVAMD. For DME, treatments like EYE201 aim to match the effectiveness of current therapies, which have helped patients maintain or improve their vision. In NVAMD, effective treatments have led to better vision outcomes over time, offering hope for new therapies like EYE201. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with macular edema following branch retinal vein occlusion, diabetic macular edema, or neovascular age-related macular degeneration. Participants will receive three injections of a new drug called EYE201 into the affected eye.

Inclusion Criteria

I am 50 years old or older.

Written informed consent before the first study-related activity

If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential

Exclusion Criteria

Be pregnant or breastfeeding

Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest

I had cataract or glaucoma surgery in my study eye within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple Ascending Dose (MAD) Study

Participants with macular edema following BRVO receive ascending doses of EYE201 to assess safety

12 weeks

4 visits (in-person)

Dose-finding Study

Participants with DME or NVAMD receive selected doses of EYE201 to assess safety and preliminary efficacy

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EYE201

Trial Overview The study tests the safety and effectiveness of EYE201 at various doses in two parts: one focusing on increasing doses for safety (12 participants) and another comparing two selected doses for efficacy (80 participants).

How Is the Trial Designed?

Group I: Part 2: NVAMD naïve or experienced participants - Dose 2 Experimental Treatment 1 Intervention

Group II: Part 2: NVAMD naïve or experienced participants - Dose 1 Experimental Treatment 1 Intervention

Group III: Part 2: DME naïve or experienced participants -Dose 2 Experimental Treatment 1 Intervention

Group IV: Part 2: DME naïve or experienced participants - Dose 1 Experimental Treatment 1 Intervention

Group V: Part 1 MAD - Mid-High Dose Experimental Treatment 1 Intervention

Group VI: Part 1 MAD - Low-Mid Dose Experimental Treatment 1 Intervention

Group VII: Part 1 MAD - Low Dose Experimental Treatment 1 Intervention

Group VIII: Part 1 MAD - High Dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

EyeBiotech Ltd.

Lead Sponsor

Trials

3

Recruited

1,100+

Published Research Related to This Trial

A study analyzing over 9 million adverse event reports found that glucagon-like peptide-1 receptor agonists (GLP-1RAs) are associated with a significantly lower frequency of retinal adverse events compared to other glucose-lowering medications, with a rate of 2.53 per 1000 reports for GLP-1RAs versus 6.62 per 1000 for other medications.

Despite patients on GLP-1RAs having more comorbid conditions and concomitant medications, there was no evidence linking GLP-1RAs to an increased risk of retinopathy progression, suggesting they are a safer option in this regard for treating type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System. Fadini, GP., Sarangdhar, M., Avogaro, A.[2022]

In a national study conducted over two years, only 36 cases of visual impairment due to adverse drug reactions (ADRs) were reported, with 23 cases resulting in permanent visual impairment, indicating that such occurrences are rare but significant.

Most visual impairments were linked to known medications with side effects, highlighting the need for careful monitoring of ocular ADRs, especially in populations like the elderly who may be taking multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom. Cumberland, PM., Russell-Eggitt, I., Rahi, JS.[2022]

Bisphosphonates have been linked to ocular inflammation, including newly reported cases of drug-related scleritis, highlighting a significant safety concern for patients using these medications.

Topiramate has been identified as a cause of angle-closure glaucoma, while cetirizine can lead to oculogyric crises, and retinoids are strongly associated with intracranial hypertension, indicating the need for careful monitoring of these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse ocular drug reactions recently identified by the National Registry of Drug-Induced Ocular Side Effects. Fraunfelder, FW., Fraunfelder, FT.[2018]

A review of safety alerts from major health regulatory authorities identified 38 alerts related to ocular adverse events from systemic drugs, with urological medications being the most frequently implicated.

The most common ocular issues reported were visual disorders, such as visual impairment and blurred vision, highlighting the need for physicians to monitor and address these drug-induced effects to prevent progression and potential vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. Penedones, A., Mendes, D., Alves, C., et al.[2022]

Lifitegrast 0.5% ophthalmic solution has been shown to significantly improve symptoms of dry eye disease, including corneal staining and dryness scores, based on data from four randomized controlled trials lasting 12 weeks.

The treatment is generally safe, with mild to moderate side effects like eye irritation and dysgeusia, making it a suitable option for patients who do not respond adequately to artificial tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifitegrast: a novel drug for patients with dry eye disease. Haber, SL., Benson, V., Buckway, CJ., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06664502

NCT06664502 | A 2-part Study Consisting of a Multiple ... This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/549556

A 2-part Study Consisting of a Multiple Ascending Dose ... This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular ...

3. trial.medpath.com trial.medpath.com/clinical-trial/a7908e014364131a/nct06664502-phase-1-2a-study-macular-edema-retinal-vein-occlusion

A 2-part Study Consisting of a Multiple Ascending Dose Safety ... This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9618488/

Outcomes of Over 40000 Eyes Treated for Diabetic Macula ... Laser treatment of “clinically significant macula edema” reduced the risk of moderate visual loss by 50% at 3 years but only 17% of eyes gained vision and there ...

5. healthcentral.com healthcentral.com/news/diabetic-macular-edema/new-dme-drug-shows-promise-in-phase-2-clinical-trials

This New DME Drug Shows Promise in Phase 2 Clinical ... A new drug called UBX1325 could be about as effective at improving vision in people with DME as anti-VEGF therapy, widening the playing field for treating DME.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06847854

NCT06847854 | A Study to Investigate the Safety, ... This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending ...

7. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-diabetic-macular-edema

Phase II start of oral treatment for diabetic macular edema It will investigate the efficacy, safety and tolerability of BI 1815368 as a potential oral treatment to improve vision in people with diabetic macular edema ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184870/

Persistent Diabetic Macular Edema - PubMed Central - NIH This review delineates a comprehensive array of treatment modalities for persistent DME, encompassing anti-vascular endothelial growth factor (anti-VEGF) ...

9. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/eye-disorder/dme/a-study-to-evaluate-the-safety--tolerability--pharmacok-19095.html

Clinical trial for Diabetic Macular Edema-Genentech A Mem... This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME).