A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

NCT07402876 | Recruiting Phase 3 FDA Drug

• 1 other identifier: ADX-2191-PVRL-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment

  Eight weeks

Study Arms (2)

Induction/Consolidation/Maintenance (ICM) ADX-2191 injection

EXPERIMENTAL

Drug: ICM ADX-2191 injection

Monthly ADX-2191 injection

ACTIVE COMPARATOR

Drug: Monthly ADX-2191 injection

Interventions

ICM ADX-2191 injection DRUG

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.

Induction/Consolidation/Maintenance (ICM) ADX-2191 injection

Monthly ADX-2191 injection DRUG

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.

Monthly ADX-2191 injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older; of any gender
• Biopsy proven primary vitreoretinal lymphoma
• 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
• Willingness to participate in the clinical trial as evidenced by signing of an informed consent

You may not qualify if:

• Known allergy or hypersensitivity to methotrexate
• Planned eye surgery during the clinical trial
• Women of childbearing potential who are pregnant or lactating
• 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
• Use of systemic methotrexate within one week prior to treatment

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33101, United States

RECRUITING

Central Study Contacts

Bill Cavanagh

CONTACT

781-257-3063; bcavanagh@aldeyra.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)