Actively Recruiting
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
Led by Life Biosciences Inc. · Updated on 2026-05-01
18
Participants Needed
4
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the safety and tolerability of a single dose of ER-100 in adults with optic nerve conditions, specifically Open Angle Glaucoma (OAG) and Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). The main questions it aims to answer are: * Is ER-100 safe when given as a single dose to people with OAG or NAION * What side effects may occur, if any, after taking ER-100? Participants will: * Receive a single dose of ER-100 * Undergo safety assessments including detailed eye examination and laboratory tests * Provide body fluid samples (tears, saliva, feces, urine) to help researchers understand how the drug is processed and cleared from the body * Complete questionnaires about their quality of life * Be followed for up to 5 years to monitor long-term health and vision outcomes
CONDITIONS
Official Title
Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have clear eye structures allowing safe pupil dilation for eye examination
- Able to understand the study and provide informed consent
- Aged between 40 and 85 years
- Willing and able to follow the study schedule including all visits and tests
- If able to become pregnant, agree to use a condom and one highly effective birth control method for at least 4 months after receiving ER-100
- Diagnosis of open-angle glaucoma in the study eye with eye pressure less than 30 mmHg
- Visual field test showing moderate to advanced vision loss (MD score between -6 and -20 dB) for OAG participants
- Not expected to need glaucoma surgery in the study eye within 2 months after ER-100
- Vision in study eye at least 20/80 for OAG participants
- Sudden, painless vision loss in one eye within 14 days before ER-100 for NAION participants
- Swelling of the optic nerve in the affected eye for NAION participants
- Visual field test showing vision loss consistent with optic nerve damage (MD worse than -3.0 dB) for NAION
- Difference in pupil response between eyes if only one eye affected for NAION
- Vision in affected eye between 20/40 and 2/500 for NAION participants
You will not qualify if you...
- History of optic neuritis or repeated non-injury-related eye inflammation
- Allergies to tetracycline antibiotics or steroid medications
- Moderate to severe cataracts, macular problems, or corneal issues interfering with eye testing
- Inability to keep eyes focused on target during testing
- Eye surgery including cataract or laser procedures within 3 months before ER-100
- Cancer (except basal cell skin cancer) within past 5 years
- Type 1 diabetes or poorly controlled Type 2 diabetes (A1c >7 despite treatment)
- Memory or thinking problems preventing study understanding or test completion
- Pregnant or breastfeeding
- Weakened immune system or positive tests for HIV, hepatitis B or C, or tuberculosis
- Other conditions increasing risk or affecting study results as judged by doctor
- Macular disease, advanced diabetic eye disease, or other vision-limiting eye conditions
- Eye pressure 30 mmHg or higher at screening
- Use of warfarin, dilantin, carbamazepine, or barbiturates within 14 days before or during first 8 weeks
- Other eye or vision problems affecting safety or vision testing as judged by doctor
- Prior gene therapy using adeno-associated virus (AAV)
- Diagnosed with glaucoma before age 40 (OAG participants only)
- Signs of giant cell arteritis or simultaneous NAION in both eyes (NAION participants only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Global Research Management, Inc.
Glendale, California, United States, 91204
Actively Recruiting
2
Mass Eye and Ear
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
3
Columbia University Irving Medical Center/Edward S. Harkness Eye Institute
New York, New York, United States, 10032
Not Yet Recruiting
4
Charleston Neuroscience Institute
Charleston, South Carolina, United States, 29414
Actively Recruiting
Research Team
L
Life Biosciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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