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Clinical Trials in the USA / NCT07402876
Recruiting Phase 3

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

NCT07402876 · tracked via the Priya Life Science USA tracker
Sponsor
Aldeyra Therapeutics, Inc
Phase
Phase 3
Started
2026-02
Last updated
2026-02-11

Condition(s) studied

Primary Vitreoretinal Lymphoma

Investigational drug(s) / intervention(s)

ICM ADX-2191 injectionMonthly ADX-2191 injection

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.

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.

Study 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

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 21 years old or older; of any gender 2. Biopsy proven primary vitreoretinal lymphoma 3. 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 4. Willingness to participate in the clinical trial as evidenced by signing of an informed consent Exclusion Criteria: 1. Known allergy or hypersensitivity to methotrexate 2. Planned eye surgery during the clinical trial 3. Women of childbearing potential who are pregnant or lactating 4. 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 5. Use of systemic methotrexate within one week prior to treatment

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Bascom Palmer Eye Institute Miami Florida Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07402876 on ClinicalTrials.gov ↗ ← All trials in the USA