NCT07402876

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Vitreoretinal Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study