Allogenic Plasma Eye Drops for Ligneous Conjunctivitis

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: Dorothy Bautista, MD

Disqualifiers: Concurrent eye disease

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: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops made from allogenic plasma (donor blood components) to treat ligneous conjunctivitis, a rare condition where white, wood-like membranes form on the eyes due to a protein deficiency. The goal is to determine if these eye drops can reduce symptoms by supplying the missing protein. Participants must have a diagnosis of ligneous conjunctivitis linked to Type 1 plasminogen deficiency and should not have other eye diseases that could interfere with the treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to a potentially effective treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that allogenic plasma eye drops are likely to be safe for humans?

Research has shown that using plasma from donors as eye drops has been attempted before, particularly for treating ligneous conjunctivitis. In these cases, no safety issues arose, suggesting that the treatment is generally safe. The eye drops are made from plasma, a component of blood that aids healing. Reports indicate that these drops have been used without major problems. This is promising for safety, but discussing any potential risks with a doctor is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ligneous conjunctivitis, which typically involve surgical removal of membrane buildup and the use of steroids or immunosuppressants, allogenic plasma eye drops offer a novel approach. These drops are derived from donor plasma, providing essential proteins and growth factors that may directly aid in healing and reducing inflammation. Researchers are excited about this treatment because it targets the condition at a biological level, potentially offering a more natural and less invasive solution. Additionally, the flexible dosing regimen, ranging from every 1 to 4 hours, allows for tailored treatment based on the severity of the recurrence, which could lead to better management of symptoms.

What evidence suggests that allogenic plasma eye drops might be an effective treatment for ligneous conjunctivitis?

Research has shown that eye drops made from donated plasma can help prevent the recurrence of ligneous conjunctivitis. This rare eye condition results from a lack of plasminogen, a protein that breaks down clots. Earlier studies found that fresh frozen plasma, similar to donated plasma, effectively improved symptoms. Participants in this trial will receive Allogenic Plasma Aliquots as eye drops. Patients using these drops have experienced fewer symptoms and recurrences. This treatment provides a direct source of plasminogen, effectively managing the condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Dorothy V Bautista, MD

Principal Investigator

Memorial University of Newfoundland

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogenic plasma aliquots as eye drops to treat recurrences of ligneous conjunctivitis

Up to 2 years

Daily to every few weeks, depending on severity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Allogenic Plasma Aliquots

Trial Overview 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.

How Is the Trial Designed?

Group I: Allogenic Plasma Aliquots Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dorothy Bautista, MD

Lead Sponsor

Trials

1

Recruited

1+

Canadian Blood Services

Collaborator

Trials

24

Recruited

39,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04275232?term=AREA%5BConditionSearch%5D(%22Conjunctivitis%22)%20AND%20AREA%5BInterventionSearch%5D(%22Fibrinolytic%20Agents%22)&rank=3

Allogenic Plasma Aliquots in the Treatment of Ligneous ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12000895/

Ligneous Conjunctivitis with Plasminogen Deficiency ... The reduced concentration of functional plasminogen in serum proved to be adequate. Our case showed that recurrence can be modified with serum ...

3. withpower.com withpower.com/trial/phase-3-skin-diseases-genetic-4-2021-b4d93

Allogenic Plasma Eye Drops for Ligneous Conjunctivitis Research shows that using fresh frozen plasma, which is similar to allogenic plasma, can prevent the recurrence of ligneous conjunctivitis and improve symptoms ...

4. clinicaltrial.be clinicaltrial.be/en/details/16722?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Treatment of Ligneous Conjunctivitis in Children With Pla... No change in the size of pseudomembranes after 6 months of topical allogenic plasma administration performed according to recommendations (with/ ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/32/NCT05404932/Prot_SAP_002.pdf

Study Protocol USASK0511ST Determine efficacy of topical administration of aliquoted allogenic plasma. ... "Ligneous conjunctivitis: an autosomal recessive disorder.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370600/

Real-World Outcomes of Allogeneic Immunosafe Plasma ... It is estimated that approximately 10‒15%o patients with moderate-to-severe dry eye disease (DED) may develop a refractory form of the disease, ...