BRVO - Branch Retinal Vein Occlusion, Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD)
Conditions
Keywords
DME, Diabetic Macular Edema, NVAMD, Neovascular Age-related Macular Degeneration, BRVO, Branch Retinal Vein Occlusion
Brief summary
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.
Detailed description
In the multiple ascending dose (MAD) part of the study, 4 cohorts, each comprised of 3 participants, will receive IVT injections of EYE201 at one of 4 dosing levels in ascending order in an open label design. The participants will have previously untreated (naïve) BRVO and will receive EYE201. Participants will return for safety and efficacy assessments and sample collection study visits. Participants in the following cohort will receive their first IVT injection of EYE201 once all 3 participants in the previous cohort have received their first dose of EYE201 and completed a predefined safety assessment, and a Dose Escalation Committee has confirmed the absence of dose-limiting toxicity (DLT). Once the last participant in the MAD portion of the study has received their first dose, completed a predefined safety assessment, and the maximum tolerated dose (MTD) either has been determined or declared as not having been reached at the doses tested, 2 of the dose levels will be selected for inclusion in the Part 2 dose-finding study, based on safety and any preliminary efficacy signals observed. The dose-finding part of the study will be randomized and masked to the participants and study site personnel (except the dose preparer and unmasked injecting physician). The study will be split according to whether the participants have treatment naïve or treatment experienced DME or NVAMD.
Interventions
DRUGEYE201
EYE201 solution for intravitreal administration
Sponsors
EyeBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant, Investigator, Outcomes Assessor
Intervention model description
Part 1 is a multiple ascending dose (MAD) study, and patients will be enrolled sequentially in ascending order through the dose levels until the highest level is reached or until a maximum tolerated dose is reached, whichever comes first. Part 2 is a randomized double-masked study where patients on all arms may be enrolled in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Best- Corrected Visual Acuity | 12 Weeks |
Countries
Puerto Rico, United States
Outcome results
None listed