A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

Conditions

• Primary Vitreoretinal Lymphoma

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ICM ADX-2191 injection — DRUG
  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.
• Monthly ADX-2191 injection — DRUG
  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.

Study Details

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

Key Dates

Start date

Feb 28, 2026

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Induction/Consolidation/Maintenance (ICM) ADX-2191 injection
• Active Comparator: Monthly ADX-2191 injection

Primary Outcome Measure

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 ]

Central Contacts

• Bill Cavanagh
  781-257-3063
  [email protected]

Locations (1)

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