A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEyeBiotech Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Be ≥ 50 years of age
Disqualifiers
Pregnant or breastfeeding
History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
Currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
Trial design
Design model
Parallel
Treatments tested in this trial
EYE103
DrugEYE103 is a humanized antibody formulated for intravitreal administration
Aflibercept 2.0 mg
DrugAflibercept 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.
Treatment groups
160 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Treatment Naïve NVAMD - Low Dose EYE103Experimental treatment 1 intervention
Group B: Treatment Naïve NVAMD - High Dose EYE103Experimental treatment 1 intervention
Group C: IR NVAMD - Low Dose EYE103Experimental treatment 1 intervention
Group D: IR NVAMD - High Dose EYE103Experimental treatment 1 intervention
Group E: IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mgExperimental treatment 2 interventions
Group F: IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mgExperimental treatment 2 interventions
Group G: Treatment Naïve BRVO - Low Dose EYE103Experimental treatment 1 intervention
Group H: Treatment Naïve BRVO - High Dose EYE103Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame
Week 12Secondary outcomes
1
Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)
Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)
Time frame
Duration of the study, through Week 122
Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame
Duration of the study, through Week 12Sponsors and contacts
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Source ClinicalTrials.gov