A Phase 1 interventional study of Mitomycin c in Pterygium, sponsored by Egymedicalpedia. Completed at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Egymedicalpedia · Phase 1, Interventional, and Treatment
Pterygium is a disease associated with proliferation of the fibrovascular tissues of the conjunctiva into the cornea and is related to factors such as ultraviolet light exposure, chronic stimulation, inflammation, climate, and genetics.
The first line of treatment for primary pterygium is surgical excision, and despite postoperative adjuvant therapy using mitomycin C, cyclosporine, β-irradiation, argon laser, and bevacizumab, recurrence rates remain high .
Mitomycin C is a metabolic inhibitor extracted from Streptomyces caespitosus that inhibits DNA synthesis .
Cyclosporine is an immunosuppressant that selectively suppresses T-helper cells, controls interleukin synthesis and secretion, and inhibits vascular endothelial growth factor (VEGF)
Bevacizumab is an anti-VEGF antibody that inhibits angiogenesis. Each agent has been studied as an adjuvant therapy to inhibit post-surgery pterygium recurrence.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the First Group and consists of !9 Patients and received 0.02% topical mitomycine C , 4 times per day for five days after the surgery.
Drug: Mitomycin c
This is the Second Group and consists of !9 Patients and received topical 0.05% Cyclosporine, 4 times per day for three months after the surgery.
Drug: Mitomycin c
This is the Third Group and consists of !9 Patients and received artificial eye drops, 4 times per day for three months after the surgery.
Drug: Mitomycin c
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
Also known as: Cyclosporine
Post Operative recurrence of pterygium
According to the anterior segment slit lamp examination, grade 0 will be defined as no recurrence; grade 1 will be defined as thin episcleral blood vessels, not accompanied by fibrosis, observed around the excised area; grade 2 will be defined as fibrovascular proliferation limited to the sclera in the area will be excised; grade 3 will be defined as fibrovascular proliferation crossing the corneal limbus. Grades 2 and 3 will be defined as recurrence.
Time frame: from baseline to 3 months after primary pterygium surgery.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Jun 2022, 17 months.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mitomycin