RecruitingPhase 3

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

United States20 participantsStarted 2026-02

Plain-language 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

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: Eight weeks

Trial details

NCT IDNCT07402876

SponsorAldeyra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Bill Cavanagh

781-257-3063 bcavanagh@aldeyra.com

View on ClinicalTrials.gov More Primary Vitreoretinal Lymphoma trials