A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration

Launched by EYEBIOTECH LTD. · Oct 28, 2024

Keywords

ClinConnect Summary

The EYE-TIE-201 clinical trial is testing a new drug called EYE201 to see how safe and effective it is for treating certain eye conditions, including diabetic macular edema (DME), neovascular age-related macular degeneration (NVAMD), and macular swelling caused by branch retinal vein occlusion (BRVO). The study has two parts: the first part will involve about 12 participants with BRVO who will receive three injections of EYE201 over 12 weeks, while the second part will include around 80 participants with either DME or NVAMD. This second part aims to find the best doses of the drug and will also assess its effectiveness.

To be eligible for the trial, participants must be at least 18 years old and meet specific health criteria, such as having certain levels of vision and eye conditions. They will need to provide informed consent before starting the study. Throughout the trial, participants can expect to receive three injections of the study drug, spaced four weeks apart, and will be monitored for any side effects. This research is important because it could lead to new treatments for serious eye conditions that can affect vision.

Gender

ALL

Eligibility criteria

• • General Key Inclusion Criteria
• • Written informed consent before the first study-related activity
• • Be male or female ≥ 18 years of age
• • 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.
• • General Key Exclusion Criteria
• • Be pregnant or breastfeeding
• • Have a history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
• • Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest.
• • Have had Yttrium-Aluminum Garnet laser capsulotomy in the study eye within 90 days of Screening
• • Have had Pan-retinal Photocoagulation or focal thermal laser photocoagulation in the study eye
• • Have tractional retinal detachment in the study eye
• • Have uncontrolled glaucoma (defined as IOP ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
• • BRVO-specific Inclusion Criteria
• Participants must:
• • Be diagnosed with BRVO in the study eye
• • Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• • Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• • Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO BRVO-specific Exclusion Criteria
• Participants must not:
• • Have macular edema in the study eye considered to be secondary to a cause other than BRVO (e.g., DME, Irvine-Gass syndrome)
• • Have active iris or angle neovascularization or neovascular glaucoma in the study eye
• • Have proliferative retinopathy, central retinal vein occlusion, or hemiretinal vein occlusion
• • DME-specific Inclusion Criteria
• Participants must:
• • Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
• • Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• • Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• • Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of DME
• • DME-specific Exclusion Criteria
• Participants must not:
• • Have macular edema in the study eye considered to be secondary to a cause other than DME (eg, retinal vein occlusion, Irvine-Gass syndrome)
• • Have active iris or angle neovascularization or neovascular glaucoma in the study eye
• • Have high-risk proliferative diabetic retinopathy characteristics in the study eye
• • NVAMD-specific Inclusion Criteria
• Participants must:
• • Be ≥ 50 years of age
• • Have a ETDRS BVCA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• • Subfoveal CNV secondary to AMD, with a total lesion size (including blood, scar/atrophy \& neovascularization) of ≤ 9-disc areas, of which at least 50% must be active CNV in the study eye
• • Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• • Be treatment naïve with vision loss in the study eye secondary to NVAMD diagnosed within 21 days prior to the Day 1 study treatment NVAMD-specific Exclusion Criteria
• Participants must not:
• • Have had previous thermal subfoveal laser therapy in the study eye
• • Have any subfoveal atrophy or scarring, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy
• • Have had previous photodynamic therapy with Visudyne in the study eye
• • Have diabetic retinopathy in the study eye