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
Aldeyra Therapeutics, Inc.
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
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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-ocula…
Interventions
- DrugICM ADX-2191 injection
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.
- DrugMonthly ADX-2191 injection
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.
Location
- Bascom Palmer Eye InstituteMiami, Florida