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

Trial Summary

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.

What safety data exists for EYE201 treatment for eye conditions?

There is no specific safety data available for EYE201 in the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lifitegrast: a novel drug for patients with dry eye disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom. [2022]