Recruiting
Phase 3

ADX-2191

Sponsor:

Aldeyra Therapeutics, Inc.

Code:

NCT07402876

Conditions

Primary Vitreoretinal Lymphoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

ICM ADX-2191 injection

Monthly ADX-2191 injection

Study Details

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

Study ID

NCT07402876

Start date

Feb, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

active comparator: Monthly ADX-2191 injection

Interventions

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.

Primary outcome measure

  • Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment [ Time Frame: Eight weeks ]

Central Contacts and Locations

Central contacts

Bill Cavanagh

781-257-3063bcavanagh@aldeyra.com

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33101

Contacts

Basil Williams, MD

305-243-2285basilkwilliams@med.miami.edu

More Information

Sponsor

Aldeyra Therapeutics, Inc.

Last update posted

Feb 11, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aldeyra Therapeutics, Inc. on 2026-02-11.