NCT07402876PHASE3Recruiting
A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma
Aldeyra Therapeutics, Inc.
Start Date
2/1/2026
Completion Date
12/1/2026
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 Criteria
Age Range: 21 years to No maximum
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
Interventions
DRUG
ICM ADX-2191 injection
DRUG
Monthly ADX-2191 injection
Conditions
Primary Vitreoretinal Lymphoma
Locations
Bascom Palmer Eye Institute
Miami, Florida 33101
United States