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RECRUITING
NCT07402876
PHASE3

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

Sponsor: Aldeyra Therapeutics, Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-02

Completion Date

2026-12

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (1)

Bascom Palmer Eye Institute

Miami, Florida, United States