ADX-2191 for Vitreoretinal Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ADX-2191 for primary vitreoretinal lymphoma, a rare eye cancer. Researchers aim to assess the safety and effectiveness of ADX-2191 when injected into the eye. Participants will join one of two groups: one receiving regular injections and another with a different dosing schedule. Individuals diagnosed with this specific eye cancer and with lymphomatous cells in their eye fluid are suitable candidates for the trial. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.
Do I need to stop my current medications for the trial?
The trial requires that you stop using systemic methotrexate at least one week before starting treatment. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ADX-2191, a treatment for primary vitreoretinal lymphoma, has not raised any major safety concerns. Studies found that the FDA identified no safety or manufacturing issues with ADX-2191, indicating that patients generally tolerate the treatment well. Additionally, the FDA granted orphan drug status to ADX-2191 for other conditions, which involved a detailed review of safety data. Although the FDA did not approve it for primary vitreoretinal lymphoma due to insufficient evidence of effectiveness, safety was not a factor in the denial. Thus, the treatment appears safe for use.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for vitreoretinal lymphoma, which typically involve radiation and chemotherapy, ADX-2191 offers a unique approach by being directly injected into the eye. This method allows the drug to target the lymphoma cells more precisely, potentially leading to fewer side effects compared to systemic treatments. Researchers are excited about ADX-2191 because it has the potential to provide more effective and localized treatment, improving outcomes for patients with this challenging condition.
What evidence suggests that ADX-2191 might be an effective treatment for vitreoretinal lymphoma?
Research shows that ADX-2191, a new methotrexate injection tested in this trial, may help treat primary vitreoretinal lymphoma, a rare eye cancer. In earlier studies, ADX-2191 demonstrated promising results, such as reducing the risk of retinal detachment over six months compared to past data. This trial includes two treatment arms: one where participants receive an Induction/Consolidation/Maintenance (ICM) regimen of ADX-2191 injections, and another where participants receive monthly ADX-2191 injections. Europe has recognized the treatment for its potential to address this rare condition. Currently, no FDA-approved treatments exist for primary vitreoretinal lymphoma, but ADX-2191 could become the first if ongoing research continues to yield positive outcomes.23678
Are You a Good Fit for This Trial?
This trial is for adults over 21 with biopsy-proven primary vitreoretinal lymphoma. Participants must have lymphomatous cells in the vitreous part of the eye or a confirmed diagnosis after a specific eye procedure. They need to sign an informed consent to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction/Consolidation/Maintenance (ICM) Treatment
Participants receive intravitreal injections of ADX-2191 as part of the ICM treatment regimen
Monthly Treatment
Participants receive monthly intravitreal injections of ADX-2191
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADX-2191
Trial Overview
The trial tests ADX-2191, an intravitreal injection, for safety and effectiveness against primary vitreoretinal lymphoma. It's randomized and double-masked, meaning neither doctors nor patients know who gets which treatment frequency.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aldeyra Therapeutics, Inc.
Lead Sponsor
Citations
A Clinical Trial Evaluating Patients With Primary ...
Following the development of lymphomatous vitreous cells in at least one eye, subjects will follow ICM dosing with ADX-2191 intravitreal injections twice weekly ...
Top-Line Results from Part 1 of the Phase 3 GUARD Trial of ...
The primary endpoint of reduction of retinal detachment over 6 months in ADX-2191-treated patients vs. historical control* was achieved (P=0. ...
3.
onclive.com
onclive.com/view/adx-2191-scores-orphan-designation-in-europe-for-primary-lbcl-of-immune-privileged-sitesADX-2191 Scores Orphan Designation in Europe for ...
The EMA granted orphan designation to ADX-2191 for the management of LBCL of immune-privileged sites, including primary vitreoretinal lymphoma.
4.
ophthalmologytimes.com
ophthalmologytimes.com/view/aldeyra-therapeutics-receives-special-protocol-assessment-agreement-letter-from-fda-for-adx-2191Aldeyra Therapeutics receives Special Protocol ...
ADX-2191 is an investigational methotrexate injection for primary vitreoretinal lymphoma, a rare cancer with no FDA-approved treatments. The FDA ...
5.
ir.aldeyra.com
ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-positive-primary-vitreoretinalPress Release Details
“Pending FDA review, ADX-2191 could be the first FDA-approved therapy for primary vitreoretinal lymphoma, a rare but potentially fatal cancer ...
6.
ir.aldeyra.com
ir.aldeyra.com/news-releases/news-release-details/fda-accepts-priority-review-adx-2191-new-drug-applicationFDA Accepts for Priority Review ADX-2191 New Drug ...
ADX-2191 has received FDA Orphan Drug Designation for the prevention of proliferative vitreoretinopathy, and for the treatment of primary ...
FDA Denies NDA of ADX-2191 for Primary Vitreoretinal ...
Despite no safety or manufacturing issues with ADX-2191 being identified, the FDA denied the NDA based on the “lack of substantial evidence of ...
8.
ir.aldeyra.com
ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-provides-regulatory-update-adx-2191Aldeyra Therapeutics Provides Regulatory Update on ADX ...
Although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a “lack of substantial evidence of ...
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