Plasma Exchange for Optic Neuritis and Myelitis

(TIMELY-PLEX Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants, Corticosteroids, Plasma exchange, others

Disqualifiers: Pregnancy, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

382 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early initiation of plasma exchange (a process that removes certain substances from the blood) can improve outcomes for individuals with severe optic neuritis (a condition causing vision loss) and transverse myelitis (a condition causing spinal cord inflammation). Participants will receive either high-dose corticosteroids (a type of anti-inflammatory drug) or plasma exchange, with different groups starting treatment at varying times to determine the most effective approach. Suitable candidates have experienced severe optic neuritis or transverse myelitis symptoms within the last 8 days and continue to face significant vision or mobility issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

Yes, if you are taking certain immune-modulating or immunosuppressive medications, you will need to stop them before joining the trial. The specific medications and the timeframes for stopping them are listed in the trial's exclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that plasma exchange (PLEX) is generally safe and well-tolerated. Studies have used PLEX as an additional treatment for severe cases of certain nerve-related conditions. For example, it has improved vision in patients with severe optic neuritis. In one study, patients' vision improved significantly from very poor to much better after treatment.

PLEX is often combined with high-dose steroids and has been effective in about 81% of patients within six months. While PLEX is usually safe, it can sometimes cause mild side effects like low blood pressure or dizziness during the procedure. Serious risks are rare.

Since this trial is in a later phase, earlier studies have demonstrated PLEX's safety, and it is considered well-tolerated in humans. For those considering joining this trial, the available data supports the safety of PLEX as a treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential of plasma exchange (PLEX) as an early intervention for severe optic neuritis and transverse myelitis. Unlike the standard of care, which typically involves high-dose corticosteroids to reduce inflammation, PLEX directly removes harmful antibodies and inflammatory substances from the blood, potentially leading to faster and more significant recovery. This approach could offer a new way to manage these conditions by targeting the underlying immune response more effectively and quickly, especially when administered soon after symptom onset.

What evidence suggests that this trial's treatments could be effective for Optic Neuritis and Transverse Myelitis?

This trial will compare the effectiveness of plasma exchange (PLEX) in treating optic neuritis and transverse myelitis. Studies have shown that PLEX can effectively treat optic neuritis, a condition affecting vision. In one study, 43% of eyes improved to perfect 20/20 vision after PLEX, while only 20.5% remained at poor vision levels of 20/200 or worse. For transverse myelitis, research has shown that 81% of patients experienced significant improvement when PLEX was added to their treatment. Many patients report better function and less disability over time. These findings suggest that PLEX can improve outcomes for both optic neuritis and transverse myelitis, especially when used early. Participants in this trial will be assigned to different arms to evaluate the timing and effectiveness of PLEX for these conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

John Chen

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with severe forms of Optic Neuritis or Transverse Myelitis, which are conditions affecting the eyes and spinal cord. Participants should not have infections causing these issues. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have noticeable muscle weakness.

My disability level is moderate or severe, not counting vision or brain function issues.

Able to sign and date informed consent form

Exclusion Criteria

I haven't had CD20 or CD19 therapy in the last 6 months.

I have not had a plasma exchange in the last 3 months.

I have not taken Teriflunomide in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive early or rescue Therapeutic Plasma Exchange (PLEX) treatment for severe Optic Neuritis or Transverse Myelitis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of visual and neurological outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• High-dose corticosteroids
• PLEX

Trial Overview The study is testing whether using Therapeutic Plasma Exchange (PLEX) early on, along with high-dose corticosteroids (HDCS), leads to better outcomes compared to using PLEX as a rescue treatment after HDCS alone in severe cases of Optic Neuritis and Transverse Myelitis.

How Is the Trial Designed?

Group I: Transverse Myelitis "Early PLEX" Experimental Treatment 1 Intervention

Adult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)

Group II: Optic Neuritis (ON) "Early PLEX" Experimental Treatment 1 Intervention

Adult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse

Group III: Transverse Myelitis "Rescue PLEX" Active Control 1 Intervention

Adult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)

Group IV: Optic Neuritis (ON) "Rescue PLEX" Active Control 1 Intervention

Adult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36822570/

Visual Outcomes Following Plasma Exchange for Optic Neuritis Conclusion: Most ON attacks improved with PLEX, and outcomes were better than attacks with similar severity in the ONTT. The presence of severe ...

2. ajo.com ajo.com/article/s0002-9394(23)00066-1/fulltext

Visual Outcomes Following Plasma Exchange for Optic ... One hundred sixty-nine eyes (43%) improved to 20/20 after PLEX (Figure 2). However, the final outcome was 20/200 or worse in 81 (20.5%) optic ...

3. aao.org aao.org/education/editors-choice/plasma-exchange-optic-neuritis-is-becoming-more-po

Plasma Exchange for Optic Neuritis Is Becoming More ... Positive outcomes in other recent retrospective studies have increased support for the use of PLEX in cases of optic neuritis, and the results ...

4. pcori.org pcori.org/research-results/2024/treatment-inflammatory-myelitis-and-optic-neuritis-early-versus-rescue-plasma-exchange

Treatment of Inflammatory Myelitis and Optic Neuritis With ... This study compares the effectiveness of two different treatment approaches, early versus rescue plasma exchange, for transverse myelitis (TM) and optic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0035378725005454

Criteria for the use of plasmapheresesis in optic neuritis Several studies have shown that plasmapheresis (PE) can improve visual prognosis in the absence of satisfactory recovery after corticosteroids. However, there ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7360232/

Safety and efficacy of plasma exchange for the treatment of ... It is traditionally believed that PLEX should be given as an additional treatment or salvage therapy for NMOSD patients with extremely severe ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034817300408

Clinical outcomes and predictive factors related to good ... Plasma exchange following IVMP therapy led to a significant improvement in 81% of the cases after 6 months of follow up. A baseline Expanded Disability Status ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000213903

Outcomes After Acute Plasma Exchange for Myelin ... A total of 239 (99%) attacks were also treated with corticosteroids and 32 (13%) with IV immunoglobulins. VA in optic neuritis improved from 20/400 (20/70–hand ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07100990

Treatment of Inflammatory Myelitis and Optic Neuritis With ... The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in ...

10. mdpi.com mdpi.com/2075-4418/14/9/863

Visual Function Improvement after Plasma Exchange ... This study revealed that PLEX treatment effectively improves the visual outcomes of patients experiencing their first attack of severe acute isolated ON after ...