A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by Aldeyra Therapeutics, Inc.
Sponsor
Aldeyra Therapeutics, Inc.
Information Provided by (Responsible Party)
Aldeyra Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT07402876
Other Study ID Numbers:
ADX-2191-PVRL-001
First Submitted
January 28, 2026
First Posted
February 10, 2026
Last Update Posted
February 10, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Primary Vitreoretinal Lymphoma
Drug: ICM ADX-2191 injectionDrug: Monthly ADX-2191 injection

Study Design

Study TypeInterventional
Actual Enrollment20 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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
Study Start DateJanuary 31, 2026
Actual Primary Completion Date6mos 3w from now
Actual Study Completion Date6mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Induction/Consolidation/Maintenance (ICM) ADX-2191 injection
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.
Monthly ADX-2191 injection
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.

Outcome Measures

Primary Outcome Measures
  1. Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsAldeyra Therapeutics, Inc.
Locations
Bascom Palmer Eye Institute | Miami Florida, United States, 33101