What is ADX-2191 studying for primary vitreoretinal lymphoma?

ADX-2191 is being studied to evaluate its safety and ability to clear lymphoma cells from the eye in patients with primary vitreoretinal lymphoma. This trial is a randomized, controlled study sponsored by Aldeyra Therapeutics, Inc. It aims to compare different dosing schedules to better understand treatment activity.

Who may be eligible for this primary vitreoretinal lymphoma clinical trial?

Adults 21 years or older with biopsy-proven primary vitreoretinal lymphoma who have lymphomatous vitreous cells or have had a vitrectomy are eligible. Both men and women can participate, but people with methotrexate allergy or planned eye surgery are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this primary vitreoretinal lymphoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

Age: 21Years +

All Genders

ID07402876

Phase 3 Study of ADX-2191 Injections to Treat Primary Vitreoretinal Lymphoma Comparing Different Injection Schedules in Adult Patients

Led by Aldeyra Therapeutics, Inc. · Updated on 2026-02-11

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and activity of ADX-2191 methotrexate injection USP given directly into the eye for patients with primary vitreoretinal lymphoma. This Phase 3, multicenter, randomized, double-masked clinical trial compares different dosing schedules to understand how well they clear lymphoma cells from the eye. Participants will receive one of two treatment methods after developing lymphomatous vitreous cells in at least one eye. One group will follow the InductionConsolidationMaintenance ICM dosing of ADX-2191, receiving intravitreal injections twice weekly for four weeks, then weekly for eight weeks, totaling sixteen injections. The other group will receive monthly ADX-2191 injections for three months, with sham injections during other visits for a total of thirteen sham injections. During the study, participants will be monitored for the clearance of lymphoma cells in the eye over eight weeks. The main measure is the proportion of patients whose vitreous cells clear after treatment. Safety and response will be assessed through regular visits and evaluations. The trial will continue until December 2026, with all study-related care provided under careful observation.

CONDITIONS

Brief Title

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

Who Can Participate

Age: 21Years +

All Genders

Eligibility Criteria

You may qualify if you...

21 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 will not qualify if you...

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 could interfere with the conduct or interpretation of the clinical trial
Use of systemic methotrexate within one week prior to treatment

Research Team

Bill Cavanagh

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