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NCT07402876Phase 3RECRUITING

A Clinical Trial Evaluating Patients With Primary Vitreoretinal Lymphoma

Study Summary

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
Primary Vitreoretinal Lymphoma
Interventions / Drugs
ICM ADX-2191 injectionMonthly ADX-2191 injection
View on ClinicalTrials.gov ↗
Sponsor
ALDX
Aldeyra Therapeutics
Ophthalmology
D41/100
Study Details
Enrollment20 participants
Primary Completion—
Lead SponsorAldeyra Therapeutics, Inc.
Data Retrieved2026-04-11 02:53:10.962452+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 20 participants
Sponsor Catalyst Profile

Aldeyra Therapeutics (ALDX) is the sponsoring company for this trial. BiotechSign currently grades this company D (41/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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