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Tests treatment safety and results for Open Angle Glaucoma (OAG)
Official title Evaluating ER-100 for Safety in People With Glaucoma or Non-Arteritic Anterior Ischemic Optic Neuropathy (Optic Nerve Conditions)
ClinicalTrials.gov ID: NCT07290244
What this study is testing
What is ER-100 epigenetic therapy?
ER-100 epigenetic therapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for open angle glaucoma (oag).
Also referred to as OSK epigenetic therapy, Investigational epigenetic therapy for optic neuropathies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Have clear eye structures and be able to have your pupils safely dilated so the doctor can examine the back of your eye.
- Able to understand the study and sign a consent form.
- Be between 40 and 85 years old.
- Willing and able to follow the study schedule, including all visits and tests, and speak a language for which the study materials are available.
- If a participant can become pregnant, must agree to use a condom and one highly effective form of birth control during sex for at least 4 months...
You likely can't join if
- History of optic neuritis (inflammation of the optic nerve) or repeated episodes of eye inflammation (uveitis) not caused by injury or surgery.
- Allergic reactions to tetracycline antibiotics or steroid medications.
- Moderate to severe cataracts, macular problems, or corneal issues that could interfere with eye testing.
- Unable to keep your eyes focused on a target during testing.
- Had cataract surgery or other eye surgery (including laser procedures) within 3 months before receiving the study drug.
- Had cancer (except for basal cell skin cancer) within the past 5 years.
See the full eligibility criteria
- Have clear eye structures and be able to have your pupils safely dilated so the doctor can examine the back of your eye.
- Able to understand the study and sign a consent form.
- Be between 40 and 85 years old.
- Willing and able to follow the study schedule, including all visits and tests, and speak a language for which the study materials are available.
- If a participant can become pregnant, must agree to use a condom and one highly effective form of birth control during sex for at least 4 months after receiving the study drug (ER-100). For participants with open-angle...
- Diagnosis of open-angle glaucoma in the study eye.
- Eye pressure must be less than 30 mmHg, measured with a standard test.
- Visual field test must show moderate to advanced vision loss (MD score between -6 and -20 dB).
- Not expected to need glaucoma surgery in the study eye within 2 months after receiving ER-100.
- Have reasonably good vision in the study eye (at least 20/80 on a standard eye chart). For participants with NAION (non-arteritic anterior ischemic optic neuropathy):
- Had a sudden, painless loss of vision in one eye within 14 days before receiving ER-100, confirmed by a specialist. Having had NAION in the other eye is okay.
- The affected eye must show swelling of the optic nerve.
- Visual field test must show vision loss consistent with optic nerve damage (MD worse than -3.0 dB).
- If only one eye is affected, there must be a difference in pupil response between the two eyes.
- Have vision in the affected eye between 20/40 and 2/500 on a standard eye chart.
- History of optic neuritis (inflammation of the optic nerve) or repeated episodes of eye inflammation (uveitis) not caused by injury or surgery.
- Allergic reactions to tetracycline antibiotics or steroid medications.
- Moderate to severe cataracts, macular problems, or corneal issues that could interfere with eye testing.
- Unable to keep your eyes focused on a target during testing.
- Had cataract surgery or other eye surgery (including laser procedures) within 3 months before receiving the study drug.
- Had cancer (except for basal cell skin cancer) within the past 5 years.
- Have Type 1 diabetes, or poorly controlled Type 2 diabetes (A1c greater than 7 despite treatment).
- Have memory or thinking problems that prevent you from understanding the study or completing the required tests.
- Pregnant or breastfeeding.
- Have a weakened immune system, including a history of organ transplant, or test positive for HIV, hepatitis B or C, or tuberculosis.
- Have any other condition that, in the opinion of the study doctor, could increase your risk from the study drug or procedures, affect the study results, or make it hard for you to complete the study.
- Have macular disease, advanced diabetic eye disease, or other eye conditions that limit vision in the study eye.
- Eye pressure at screening is 30 mmHg or higher.
- Taking certain medications (warfarin, dilantin, carbamazepine, or barbiturates) within 14 days before starting the study or during the first 8 weeks.
- Have any other eye or vision problem that, in the opinion of the study doctor, could affect safety or interfere with vision testing.
- Have previously received any gene therapy using adeno-associated virus (AAV). Additional Exclusion Criteria for Participants with Open-Angle Glaucoma (OAG): \- Diagnosed with glaucoma before age 40. Additional Exclusion...
- Show signs of giant cell arteritis (a type of blood vessel inflammation), based on abnormal blood tests.
- Had NAION start in both eyes at the same time.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, California, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, California, United States; Boston, Massachusetts, United States; New York, New York, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.