A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
Purpose
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.
Conditions
- Neovascular Age-Related Macular Degeneration (NVAMD)
- Branch Retinal Vein Occlusion (BRVO)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 Exclusion Criteria - 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) Key NVAMD-specific Exclusion Criteria - Have had previous thermal subfoveal laser therapy in the study eye - Have had previous photodynamic therapy with Visudyne in the study eye Key BRVO-specific Exclusion Criteria - Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, diabetic macular edema, NVAMD, Irvine-Gass syndrome) - Have active iris or angle neovascularization or neovascular glaucoma in the study eye
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Naïve NVAMD - Low Dose EYE103 |
Treatment Naïve NVAMD Cohort - Low Dose EYE103 (50 μL) |
|
|
Experimental Treatment Naïve NVAMD - High Dose EYE103 |
Treatment Naïve NVAMD Cohort - High Dose EYE103 (50 μL) |
|
|
Experimental IR NVAMD - Low Dose EYE103 |
Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) |
|
|
Experimental IR NVAMD - High Dose EYE103 |
Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) |
|
|
Experimental IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg |
Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg |
|
|
Experimental IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg |
Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg |
|
|
Experimental Treatment Naïve BRVO - Low Dose EYE103 |
Treatment Naïve BRVO Cohort - Low Dose EYE103 (50 μL) |
|
|
Experimental Treatment Naïve BRVO - High Dose EYE103 |
Treatment Naïve BRVO Cohort - High Dose EYE103 (50 μL) |
|
Recruiting Locations
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
Glendale, California 91204
Glendale, California 91204
Modesto, California 95356
Mountain View, California 94040
Sacramento, California 95825
Sacramento, California 95825
Sacramento, California 95841
Santa Ana, California 92705
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Lemont, Illinois 60439
Lemont, Illinois 60439
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Madison, Mississippi 39110
Madison, Mississippi 39110
Bloomfield, New Jersey 07003
Bloomfield, New Jersey 07003
Asheville, North Carolina 28803
Cary, North Carolina 27511
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
West Columbia, South Carolina 29169
West Columbia, South Carolina 29169
Germantown, Tennessee 38138
Knoxville, Tennessee 37922
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Abilene, Texas 79606
Amarillo, Texas 79106
Austin, Texas 78705
Austin, Texas 78705
Bellaire, Texas 77401
Bellaire, Texas 77401
Burleson, Texas 76028
Dallas, Texas 75231
Dallas, Texas 75231
Round Rock, Texas 78681
Round Rock, Texas 78781
San Antonio, Texas 78240
San Antonio, Texas 78240
San Marcos, Texas 78666
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Willow Park, Texas 76087
West Jordan, Utah 84088
More Details
- Status
- Recruiting
- Sponsor
- EyeBiotech Ltd.
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.