Comparison Between Topical Mitomycin C and Cyclosporine

Egymedicalpedia

Status and phase: Completed; Phase 1

Conditions: Pterygium

Treatments: Drug: Mitomycin c

Study type: Interventional

Funder types: Industry

Identifiers

NCT05627947

OMNEYA HEGAZY

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 57 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary pterygium
• Pterygium size > or equal 2mm (the horizontal length of the tissue from limbus to cornea will be measured by slit lamp biomicroscopy).
• Ocular discomfort refractory to medical treatment.
• Visual loss induced by pterygium.
• Adult Egyptian population

Exclusion criteria

• Patients who had recurrent pterygium or allergy to topical Cyclosporine.
• Patients who had allergy from Mitomycin C.
• Pregnant women.
• Patients with uncontrollable systemic diseases such as hypertension, diabetes, or cardiovascular diseases.
• Patients with diseases of the eye surface such as conjunctivitis and keratitis.
• Patients with a history of eye surgery within the previous six months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

mitomycine-C Group

Active Comparator group

Description:

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.

Treatment:

Drug: Mitomycin c

Cyclosporine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Mitomycin c

artificial eye drops Group

Active Comparator group

Description:

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.

Treatment:

Drug: Mitomycin c