Clinical trial · Interventional
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
NCT07402876CI-TRIAL-00103073recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Vitreoretinal Lymphoma | Primary Vitreoretinal Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICM ADX-2191 injection | Drug | — | UNRESOLVED |
| Monthly ADX-2191 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction/Consolidation/Maintenance (ICM) ADX-2191 injection
- interventionNames
- Drug: ICM ADX-2191 injection
- type
- ACTIVE_COMPARATOR
- label
- Monthly ADX-2191 injection
- interventionNames
- Drug: Monthly ADX-2191 injection
Primary outcomes (1)
- measure
- Proportion of clearance of lymphomatous vitreous cells compared across ICM and monthly ADX-2191 treatment groups after eight weeks of treatment
- timeFrame
- Eight weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.