Branch Retinal Vein Occlusion (BRVO), Neovascular Age-Related Macular Degeneration (NVAMD)
Conditions
Keywords
Neovascular Age-Related Macular Degeneration, Branch Retinal Vein Occlusion, NVAMD, BRVO
Brief summary
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion. All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.
Detailed description
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT: * one cohort of 40 treatment naïve NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy), * one cohort of 40 incomplete responder (IR) NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy), * one cohort of 40 IR NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103, to be administered in combination with aflibercept 2.0 mg * one cohort of 40 treatment naïve BRVO participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy) Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion. All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg in the study eye on Day 1. All participants will be assessed for safety and efficacy at injection visits. Treatment naïve NVAMD participants and IR NVAMD participants in the monotherapy cohort will also return 2 weeks after each injection visit for safety and efficacy assessments. Depending on the cohort, participants will be evaluated every 2 weeks or every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns. The Week 12 Visit will serve as the end of study visit for all participants.
Interventions
DRUGEYE103
EYE103 is a humanized antibody formulated for intravitreal administration
Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose EYE103.
Sponsors
EyeBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key General Inclusion Criteria • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria * Be ≥ 50 years of age * Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement * For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment Key Incomplete Responder (IR) NVAMD-specific Inclusion Criteria * Be ≥ 50 years of age * Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening * For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2 Key Branch Retinal Vein Occlusion (BRVO)-specific Inclusion Criteria * Be diagnosed with BRVO in the study eye * Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO * Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening
Exclusion criteria
Key General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart | Week 12 | Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT) | Duration of the study, through Week 12 | Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT) |
| Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart | Duration of the study, through Week 12 | Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart |
Countries
United States
Contacts
CONTACTCharles Miller, MD PhD
STUDY_DIRECTORCharles Miller, MD PhD
EyeBiotech Ltd.
Outcome results
None listed