ICM ADX-2191 injection: Following the development of lymphomatous vitreous cells in at least one eye, subjects will follow ICM dosing with ADX-2191 intravitreal injections twice weekly for four weeks, followed by weekly for eight weeks, for a total of sixteen injections.
Monthly ADX-2191 injection: Following the development of lymphomatous vitreous cells in at least one eye, subjects will dose monthly with ADX-2191 intravitreal injections for a total of three injections. Sham injections will be performed for those visits during which ADX-2191 is not injected, for a total of thirteen sham injections.
Study summary
A prospective, randomized, double-masked, dosing-frequency-controlled, multicenter clinical trial evaluating the safety and activity of intravitreally injected ADX-2191 (methotrexate injection USP) in patients with primary vitreoretinal lymphoma
Eligibility
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 21 years old or older; of any gender
2. Biopsy proven primary vitreoretinal lymphoma
3. Presence of lymphomatous vitreous cells at the Screening Visit and/or any eye that has been vitrectomized to confirm the diagnosis of primary vitreoretinal lymphoma
4. Willingness to participate in the clinical trial as evidenced by signing of an informed consent
Exclusion Criteria:
1. Known allergy or hypersensitivity to methotrexate
2. Planned eye surgery during the clinical trial
3. Women of childbearing potential who are pregnant or lactating
4. Pre-existing ocular or non-ocular conditions or diseases that, in the opinion of the investigator, could interfere with the conduct or interpretation of the clinical trial
5. Use of systemic methotrexate within one week prior to treatment
Primary outcome measure(s)
Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment — Eight weeks
Trial sites (1)
Facility
City
Region
Status
Bascom Palmer Eye Institute
Miami
Florida
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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