What side effects are associated with this type of intervention?

The most common treatments for Ligneous Conjunctivitis, particularly those involving plasminogen such as allogenic plasma aliquots, are generally well-tolerated. However, potential side effects may include mild irritation or discomfort at the application site. Other treatments for Ligneous Conjunctivitis, such as topical corticosteroids or cyclosporine, can have side effects including increased intraocular pressure, potential for infection, and ocular surface irritation. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Ligneous Conjunctivitis in the provided context. However, the investigational use of allogenic plasma aliquots as a source of plasminogen aims to break down fibrin deposits, which is a novel approach. Generally, treatments for Ligneous Conjunctivitis may include topical or systemic plasminogen, corticosteroids, and other supportive therapies to manage symptoms and prevent recurrence.

What other types of research exist?

Promising novel alternatives to Allogenic Plasma Aliquots for Ligneous Conjunctivitis may include therapies targeting coagulation and fibrinolysis pathways, such as recombinant thrombomodulin. Additionally, investigational therapies like Lacritin and Thymosin beta-4, which have shown potential in treating other ocular conditions, could be considered.

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Plasma

Allogenic Plasma Eye Drops for Ligneous Conjunctivitis

Phase 3

Waitlist Available

Led By Dorothy V Bautista, MD

Research Sponsored by Dorothy Bautista, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency

Must not have

Subject has concurrent eye disease which prevents use of the investigational drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial uses eye drops made from donated blood plasma to treat patients with a rare eye condition called ligneous conjunctivitis. The eye drops provide a missing protein that helps dissolve harmful build-up on the eyes.

Who is the study for?

This trial is for individuals diagnosed with ligneous conjunctivitis, a rare eye condition, who have Type 1 plasminogen deficiency. It's not suitable for those with other concurrent eye diseases that would interfere with the treatment.

What is being tested?

The trial tests allogenic plasma aliquots used as eye drops to provide plasminogen in treating ligneous conjunctivitis. The plasma is obtained through Canadian Blood Services following Health Canada's approval.

What are the potential side effects?

Potential side effects may include discomfort or irritation at the site of application, allergic reactions to plasma components, and possible infection risk due to the use of blood products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a rare eye condition due to a specific protein deficiency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an eye condition that prevents me from using certain medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resolution of pseudo membrane associated with ligneous conjunctivitis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Allogenic Plasma AliquotsExperimental Treatment1 Intervention

Allogenic Plasma Aliquots to be used as eye drops in the treatment of recurrences of ligneous conjunctivitis. Two drops will be administered to the affected eye, every 1 to 4 hours, depending on severity of the recurrence.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ligneous conjunctivitis is primarily treated by addressing the plasminogen deficiency that leads to fibrin-rich pseudomembrane formation on the conjunctiva. Allogenic plasma aliquots, which provide an external source of plasminogen, are a key treatment under investigation. This approach is crucial as plasminogen helps break down fibrin deposits, reducing pseudomembrane formation and alleviating symptoms. Other treatments may include topical or systemic plasminogen, corticosteroids to reduce inflammation, and surgical removal of the membranes. The emphasis on plasminogen supplementation is particularly important as it directly targets the root cause of the disease.

Topical Ocular Anti-TNFα Agent Licaminlimab in the Treatment of Acute Anterior Uveitis: A Randomized Phase II Pilot Study.Real-world evidence of treatment for relapse of noninfectious uveitis in tertiary centers in Japan: A multicenter study.World Workshop on Oral Medicine VI: a systematic review of the treatment of mucous membrane pemphigoid.