Actively Recruiting
A Phase 2 Randomized, Dose-Masked Study of Intravitreal EYE103 in Participants With Neovascular Age-Related Macular Degeneration or Macular Edema Following Branch Retinal Vein Occlusion
Led by EyeBiotech Ltd. · Updated on 2025-11-19
160
Participants Needed
49
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying intravitreal EYE103 in people with neovascular age-related macular degeneration (NVAMD) or macular edema after branch retinal vein occlusion (BRVO). This phase 2 randomized, dose-masked trial includes four patient groups, with participants randomly assigned to receive either a low or high dose of EYE103. Some groups include treatment-naïve participants, while others involve incomplete responders, including a group receiving EYE103 combined with aflibercept, a standard anti-VEGF medication. Participants will receive three injections of EYE103 in the study eye, spaced four weeks apart. Those in the combination therapy group will receive an additional aflibercept injection on the first day. The study will be conducted in sequential cohorts, with each group receiving their assigned treatment dose. Participants will have safety and effectiveness assessments at each injection visit, with some returning two weeks post-injection for extra evaluations. During the study, participants will undergo vision tests using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart and eye examinations such as slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure retinal thickness. The main outcome is the change in best-corrected visual acuity at week 12. The study concludes at the week 12 visit, which marks the end of participation for all enrolled individuals.
CONDITIONS
Brief Title
A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to understand study procedures and provide written informed consent
- Male or female aged 18 years or older
- Aged 50 years or older for NVAMD-specific groups
- Have treatment-naïve subfoveal or juxtafoveal/extrafoveal CNV with foveal involvement for NVAMD
- Diagnosis made within 21 days prior to first study treatment or screening visit for NVAMD
- Diagnosed with BRVO in the study eye
- Vision loss in the study eye primarily due to BRVO
- Treatment-naïve with vision loss and center-involving macular edema diagnosed within 9 months of screening for BRVO
You will not qualify if you...
- Pregnant or breastfeeding
- History of cataract surgery or minimally invasive glaucoma surgery in the study eye within 90 days of screening
- YAG laser capsulotomy in the study eye within 90 days of screening
- Current use of drugs known to cause retinal toxicity such as Hydroxychloroquine, pentosan polysulfate sodium, or amiodarone
- Previous thermal subfoveal laser therapy in the study eye for NVAMD
- Previous photodynamic therapy with Visudyne in the study eye for NVAMD
- Macular edema in the study eye due to causes other than BRVO (e.g., diabetic macular edema, NVAMD, Irvine-Gass syndrome)
- Active iris or angle neovascularization or neovascular glaucoma in the study eye for BRVO
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a total of 3 intravitreal injections of EYE103 spaced 4 weeks apart. Participants in one cohort also receive aflibercept 2.0 mg injection on Day 1. Safety and efficacy are assessed at each injection visit. Some participants return 2 weeks after each injection for additional safety and efficacy assessments.
3 injection visits spaced 4 weeks apart; some participants have additional visits 2 weeks after each injection
Trial Site Locations
Total: 49 locations
1
Scottsdale, Arizona
Scottsdale, Arizona, United States, 85255
Actively Recruiting
2
Scottsdale, AZ
Scottsdale, Arizona, United States, 85255
Actively Recruiting
3
Glendale, California
Glendale, California, United States, 91204
Actively Recruiting
4
Glendale, CA
Glendale, California, United States, 91204
Actively Recruiting
5
Modesto, California
Modesto, California, United States, 95356
Actively Recruiting
6
Mountain View, California
Mountain View, California, United States, 94040
Actively Recruiting
7
Sacramento, CA
Sacramento, California, United States, 95825
Actively Recruiting
8
Sactamento, California
Sacramento, California, United States, 95825
Actively Recruiting
9
Sacramento, California
Sacramento, California, United States, 95841
Actively Recruiting
10
Santa Ana, California
Santa Ana, California, United States, 92705
Actively Recruiting
11
Fort Lauderdale, Florida
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
12
Fort Lauderdale, FL
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
13
Lemont, Illinois
Lemont, Illinois, United States, 60439
Actively Recruiting
14
Lemont, IL
Lemont, Illinois, United States, 60439
Actively Recruiting
15
Hagerstown, Maryland
Hagerstown, Maryland, United States, 21740
Actively Recruiting
16
Hagerstown, MD
Hagerstown, Maryland, United States, 21740
Actively Recruiting
17
Madison, Mississippi
Madison, Mississippi, United States, 39110
Actively Recruiting
18
Madison, MS
Madison, Mississippi, United States, 39110
Actively Recruiting
19
Bloomfield, New Jersey
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
20
Bloomfield, NJ
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
21
Asheville, North Carolina
Asheville, North Carolina, United States, 28803
Actively Recruiting
22
Cary, North Carolina
Cary, North Carolina, United States, 27511
Actively Recruiting
23
Wake Forest, NC
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
24
Wake Forest, North Carolina
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
25
West Columbia, SC
West Columbia, South Carolina, United States, 29169
Actively Recruiting
26
West Columbia, South Carolina
West Columbia, South Carolina, United States, 29169
Actively Recruiting
27
Germantown, Tennessee
Germantown, Tennessee, United States, 38138
Actively Recruiting
28
Knoxville, Tennessee
Knoxville, Tennessee, United States, 37922
Actively Recruiting
29
Nashville, Tennessee
Nashville, Tennessee, United States, 37203
Actively Recruiting
30
Nashville, TN
Nashville, Tennessee, United States, 37203
Actively Recruiting
31
Abilene, Texas
Abilene, Texas, United States, 79606
Actively Recruiting
32
Amarillo, Texas
Amarillo, Texas, United States, 79106
Actively Recruiting
33
Austin, Texas
Austin, Texas, United States, 78705
Actively Recruiting
34
Austin, TX
Austin, Texas, United States, 78705
Actively Recruiting
35
Bellaire, Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
36
Bellaire, TX
Bellaire, Texas, United States, 77401
Actively Recruiting
37
Burleson, Texas
Burleson, Texas, United States, 76028
Actively Recruiting
38
Dallas, Texas
Dallas, Texas, United States, 75231
Actively Recruiting
39
Dallas, TX
Dallas, Texas, United States, 75231
Actively Recruiting
40
Plano, Texas
Plano, Texas, United States, 75075
Actively Recruiting
41
Round Rock, TX
Round Rock, Texas, United States, 78681
Actively Recruiting
42
Round Rock, Texas
Round Rock, Texas, United States, 78781
Actively Recruiting
43
San Antonio, Texas
San Antonio, Texas, United States, 78240
Actively Recruiting
44
San Antonio, TX
San Antonio, Texas, United States, 78240
Actively Recruiting
45
San Marcos, Texas
San Marcos, Texas, United States, 78666
Actively Recruiting
46
The Woodlands, Texas
The Woodlands, Texas, United States, 77384
Actively Recruiting
47
The Woodlands, TX
The Woodlands, Texas, United States, 77384
Actively Recruiting
48
Willow Park, Texas
Willow Park, Texas, United States, 76087
Actively Recruiting
49
West Jordan, Utah
West Jordan, Utah, United States, 84088
Actively Recruiting
Research Team
C
Charles Miller, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here