Plasminogen Therapy for Pink Eye

Overseen By Simona Meier, BSc, ACRP-CP.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Disqualifiers: Age 18 or older, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for Ligneous conjunctivitis, a serious eye condition caused by plasminogen deficiency. The condition leads to growths on the eyes, which can cause scarring and vision loss. The treatment involves applying donor plasma (plasminogen therapy) directly to the eyes to prevent these growths from worsening or returning. Children under 18 with this condition may be suitable candidates for the trial. Participants will receive the treatment for 2 to 6 months and will be monitored for at least 2 years. As an unphased trial, this study provides a unique opportunity for patients to access potentially beneficial treatment and contribute to medical research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this treatment is safe for use in the eyes?

Research shows that using donor plasma in the eyes is generally safe. Studies have found that similar plasma treatments for eye conditions are well-tolerated. For example, plasma drops from donors have effectively treated certain eye diseases without causing serious side effects.

In this study, Canadian Blood Services provides the plasma, which will be used as eye drops. While every treatment carries some risk of side effects, previous studies suggest that any negative effects are usually mild. Some reports indicate that plasma therapy can be a safe option when other treatments aren't suitable.

For any safety concerns, discussing them with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about plasminogen therapy for pink eye because it uses aliquoted allogeneic donor plasma, which is a novel approach. Unlike standard treatments like antibiotic or antiviral eye drops that target bacteria or viruses causing the infection, this therapy leverages natural proteins found in plasma to potentially enhance healing directly at the source. This unique mechanism could offer a new way to reduce inflammation and speed up recovery, especially for cases that don't respond well to conventional treatments.

What evidence suggests that this treatment might be an effective treatment for pink eye?

Research has shown that applying donor plasma to the eyes can help manage ligneous conjunctivitis, a severe form of pink eye often found in individuals with plasminogen deficiency. Studies indicate that using plasminogen, either as a concentrate or through plasma, prevents the harmful growths in the eyes from worsening or returning. Clinical evidence supports that this method can stop lesions from reappearing after treatments like surgery or steroid drops. In this trial, participants will receive donor plasma, which functions similarly to plasminogen concentrate and has shown promise in treating this condition. Applied directly to the eyes, it has improved symptoms and prevented new lesions. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children under 18 with Ligneous Conjunctivitis, a type of pink eye caused by plasminogen deficiency. They must have pseudomembranous lesions and low serum plasminogen levels (<50%). It's not for adults or those without this specific condition.

Inclusion Criteria

I have eye inflammation due to low plasminogen levels.

I have been diagnosed with plasminogen deficiency.

I am under 18 years old.

Exclusion Criteria

I do not have a plasminogen deficiency.

I do not have eye symptoms due to plasminogen deficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Topical administration of aliquoted allogenic plasma to the affected eye every 1-5 hours daily

2 to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Aliquoted Allogeneic Donor Plasma

Trial Overview The study tests the use of donor plasma applied directly to the eyes of kids with Ligneous Conjunctivitis. The treatment lasts 2-6 months based on how severe the disease is and how well the patient responds, with possible re-treatment if symptoms return.

How Is the Trial Designed?

Group I: Intervention arm (aliquoted plasma application into the conjunctiva) Experimental Treatment 1 Intervention

This is the only arm of the study. The intervention is administration of aliquoted plasma provided by Canadian Blood Services in eye droppers (3 ml aliquots in 7 ml vials) in the patient's conjunctiva. The duration of therapy can be 2 to 6 months depending on response The intra-ocular drops will be administered every 1-5 hours daily in the affected eye based on disease severity and may be repeated

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Canadian Blood Services

Collaborator

Trials

24

Recruited

39,200+

Citations

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

Study Protocol USASK0511ST will receive with the plasma aliquots13. Dose. 1-2 drops (0.5-2.5 mL) of aliquoted donor plasma will be applied to the affected eye every 1-5.

2. withpower.com withpower.com/trial/phase-conjunctivitis-5-2022-2489f

Plasminogen Therapy for Pink Eye Aliquoted Allogeneic Donor Plasma. Trial Overview The study tests the use of donor plasma applied directly to the eyes of kids with Ligneous Conjunctivitis.

3. 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 ... An arm type in which a group of participants receives an intervention/treatment considered to be effective ... See Delay Results Type in the Results Data Element ...

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

Real-World Outcomes of Allogeneic Immunosafe Plasma ... Allogeneic is-ePRGF derived from healthy donors significantly improved both symptoms and clinical signs, showing a safety profile in patients ...

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

Ligneous Conjunctivitis with Plasminogen Deficiency ... Our case showed that recurrence can be modified with serum eye drops prepared from a relative with proven PPA, and disease exacerbations can ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40715787/

Real-World Outcomes of Allogeneic Immunosafe Plasma ... Allogeneic is-ePRGF was a safe and effective alternative for refractory OSD when autologous sources were not available or suitable.

7. researchgate.net researchgate.net/publication/368298615_Allogeneic_Fresh_Frozen_Plasma_for_the_Treatment_of_Ocular_Graft-Versus-Host-Disease_Prospective_Phase_2_Open-Label_Study

Allogeneic Fresh Frozen Plasma for the Treatment of ... Purpose To evaluate the safety and efficacy of allogeneic fresh frozen plasma drops for the treatment of chronic ocular graft-versus-host ...