Intravitreal ADX-2191 (methotrexate) injections for primary vitreoretinal lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Bascom Palmer Eye Institute
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Bill Cavanagh
• Email: bcavanagh@aldeyra.com
• Phone: 781-257-3063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.