Glaucoma Clinical Trials

⁃ Age 22-85 years

⁃ Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:

∙ uncontrolled by maximally tolerated medical therapy

‣ failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)

‣ failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)

‣ or have any other condition (e.g., conjunctival scarring, uveitis) in which conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma.

⁃ Primary open-angle or traumatic glaucoma.

⁃ Medicated DIOP ≥25 mmHg and ≤45 mmHg on maximum-tolerated medical therapy that is stable for at least 30 days.

⁃ Best-corrected baseline visual acuity of light perception or better in study eye.

⁃ Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

∙ Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;

‣ Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or

‣ Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

⁃ Visual field mean deviation (MD) by Humphrey Visual Field:

• Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:

• A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot;