RecruitingPhase 3NCT07402876

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

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


Sponsor

Aldeyra Therapeutics, Inc.

Enrollment

20 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a treatment for primary vitreoretinal lymphoma — a rare cancer that affects the jelly-like fluid (vitreous) inside the eye and the retina. The study involves injecting a chemotherapy drug (methotrexate) directly into the eye. **You may be eligible if...** - You are 21 years old or older - You have been diagnosed with primary vitreoretinal lymphoma confirmed by biopsy - Cancer cells are present in the vitreous fluid of your eye at the screening visit **You may NOT be eligible if...** - You are allergic to methotrexate - You are planning to have eye surgery during the trial - You are pregnant or breastfeeding (if you are a woman of childbearing age) - You have other eye conditions that could interfere with the study - You received systemic methotrexate within one week before starting the trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICM 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.

DRUGMonthly 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.


Locations(1)

Bascom Palmer Eye Institute

Miami, Florida, United States

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NCT07402876