Intravitreal ADX-2191 (methotrexate) injections for 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
This trial tests whether different schedules of intravitreal ADX-2191 (methotrexate) injections are safe and active for adults with biopsy-proven primary vitreoretinal lymphoma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Aldeyra Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07402876 on ClinicalTrials.gov |
What this trial studies
This randomized, double-masked, dosing-frequency-controlled phase 3 trial gives adults with biopsy-proven primary vitreoretinal lymphoma intravitreal injections of ADX-2191 (methotrexate injection USP) and compares different injection schedules. Participants are assigned to either an ICM dosing arm or a monthly dosing arm and are followed at specialized centers for ocular response and safety outcomes. Key eligibility includes presence of lymphomatous vitreous cells or a diagnostic vitrectomy and excludes methotrexate allergy, recent systemic methotrexate, pregnancy or planned eye surgery. The trial is sponsored by Aldeyra Therapeutics and is being conducted at ophthalmology centers including the Bascom Palmer Eye Institute in Miami, FL.
Who should consider this trial
Good fit: Adults aged 21 or older with biopsy-proven primary vitreoretinal lymphoma and detectable lymphomatous vitreous cells or prior diagnostic vitrectomy who can attend scheduled visits are ideal candidates.
Not a fit: Patients with methotrexate allergy, those planning eye surgery, pregnant or breastfeeding women, or those who recently received systemic methotrexate are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could define a better tolerated, evidence-based intravitreal methotrexate dosing strategy that controls ocular lymphoma while reducing side effects.
How similar studies have performed: Intravitreal methotrexate has shown ocular activity in prior reports, but randomized phase 3 comparisons of dosing frequency are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Bill Cavanagh
- Email: bcavanagh@aldeyra.com
- Phone: 781-257-3063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.