Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06664502
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06664502
Study Brief:
Protocol Section:
NCT06664502