Phase 1 Glaucoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have clear eye structures and whose pupils can be safely dilated for an eye examination.
• People who are able to understand the study and sign a consent form.
• People who are between 40 and 85 years old.
• People who are willing and able to follow the study schedule, including all visits and tests, and who speak a language for which the study materials are available.
• People who are capable of becoming 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 people with open-angle glaucoma (OAG):

• People who have been diagnosed with open-angle glaucoma in the eye being studied.
• People whose eye pressure is less than 30 mmHg, as measured by a standard test.
• People whose visual field test shows moderate to advanced vision loss (a score between -6 and -20 dB).
• People who are not expected to need glaucoma surgery in the study eye within 2 months after receiving ER-100.
• People who have at least 20/80 vision in the study eye, as measured on a standard eye chart.

For people with NAION (a condition causing sudden vision loss due to reduced blood flow to the optic nerve):

• People who experienced a sudden, painless loss of vision in one eye within 14 days before receiving ER-100, confirmed by a specialist — having had this condition in the other eye previously is acceptable.
• People whose affected eye shows swelling of the optic nerve.
• People whose visual field test shows vision loss consistent with optic nerve damage (a score worse than -3.0 dB).
• People where only one eye is affected must show a difference in pupil response between the two eyes.
• People whose vision in the affected eye falls between 20/40 and 2/500 on a standard eye chart.

Who may not be able to join:

• People with a history of optic nerve inflammation or repeated episodes of eye inflammation not caused by injury or surgery.
• People with known allergic reactions to tetracycline antibiotics or steroid medications.
• People with moderate to severe cataracts, macular problems, or corneal issues that could interfere with eye testing.
• People who are unable to keep their eyes focused on a target during testing.
• People who have had cataract surgery or other eye surgery, including laser procedures, within 3 months before receiving the study drug.
• People who have had cancer, except for basal cell skin cancer, within the past 5 years.
• People who have Type 1 diabetes, or poorly controlled Type 2 diabetes (an A1c greater than 7 despite treatment).
• People who have memory or thinking difficulties that would prevent them from understanding the study or completing the required tests.
• People who are pregnant or breastfeeding.
• People who have a weakened immune system, including a history of organ transplant, or who test positive for HIV, hepatitis B or C, or tuberculosis.
• People who have any other condition that, in the study doctor's opinion, could increase risk from the study drug or procedures, affect study results, or make it difficult to complete the study.
• People who have macular disease, advanced diabetic eye disease, or other eye conditions that limit vision in the study eye.
• People whose eye pressure is 30 mmHg or higher at the screening visit.
• People who have taken certain medications — warfarin, dilantin, carbamazepine, or barbiturates — within 14 days before starting the study or during the first 8 weeks.
• People who have any other eye or vision problem that, in the study doctor's opinion, could affect safety or interfere with vision testing.
• People who have previously received any gene therapy using adeno-associated virus (AAV).

Additional criteria for people with open-angle glaucoma:

• People who were diagnosed with glaucoma before the age of 40 may not be eligible.

Additional criteria for people with NAION:

• People whose blood tests show signs of giant cell arteritis, a type of blood vessel inflammation, may not be eligible.
• People whose NAION began in both eyes at the same time may not be eligible.

Important: Always verify eligibility with the trial site directly before applying.