A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICM ADX-2191 injection, Monthly ADX-2191 injection.
- Who it may be relevant to
- Registry conditions: Primary Vitreoretinal Lymphoma. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug 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. - Drug 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 measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bascom Palmer Eye Institute — Miami
Identifiers
NCT: NCT07402876 · ADX-2191-PVRL-001