RecruitingRecruiting
A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma
NCT07402876 · Aldeyra Therapeutics, Inc.
In plain English
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Official 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
About this study
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
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 target: 20 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-02
Estimated completion: 2026-12
Last updated: 2026-02-11
Interventions
Drug: ICM ADX-2191 injectionDrug: Monthly ADX-2191 injection
Primary outcomes
- • Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment (Eight weeks)
Sponsor
Aldeyra Therapeutics, Inc. · industry
Contacts & investigators
ContactBill Cavanagh · contact · bcavanagh@aldeyra.com · 781-257-3063
All locations (1)
Bascom Palmer Eye InstituteRecruiting
Miami, Florida, United States