Bascom Palmer Eye Institute
Miami, Florida, 33101, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07402876
A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ICM ADX-2191 injection
DrugFollowing 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
DrugFollowing 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 outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Aldeyra Therapeutics, Inc.
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 11, 2026
- Registry last updated
- Feb 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.