Actively Recruiting
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
Led by Aldeyra Therapeutics, Inc. · Updated on 2026-02-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and activity of ADX-2191 (methotrexate injection USP) given directly into the eye for patients with primary vitreoretinal lymphoma. This Phase 3, multicenter, randomized, double-masked clinical trial compares different dosing schedules to understand how well they clear lymphoma cells from the eye. Participants will receive one of two treatment methods after developing lymphomatous vitreous cells in at least one eye. One group will follow the Induction/Consolidation/Maintenance (ICM) dosing of ADX-2191, receiving intravitreal injections twice weekly for four weeks, then weekly for eight weeks, totaling sixteen injections. The other group will receive monthly ADX-2191 injections for three months, with sham injections during other visits for a total of thirteen sham injections. During the study, participants will be monitored for the clearance of lymphoma cells in the eye over eight weeks. The main measure is the proportion of patients whose vitreous cells clear after treatment. Safety and response will be assessed through regular visits and evaluations. The trial will continue until December 2026, with all study-related care provided under careful observation.
CONDITIONS
Brief Title
A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 could interfere with the conduct or interpretation of the clinical trial
- Use of systemic methotrexate within one week prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive intravitreal injections of ADX-2191. One group receives ICM dosing with injections twice weekly for four weeks, then weekly for eight weeks, totaling sixteen injections. Another group receives monthly injections for a total of three injections, with sham injections on other monthly visits.
Twice weekly visits for 4 weeks, then weekly visits for 8 weeks for one group; monthly visits for 3 months for the other group
Trial Site Locations
Total: 1 location
1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33101
Actively Recruiting
Research Team
B
Bill Cavanagh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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