PterygiumPhase 1NCT05627947
Comparison Between Topical Mitomycin C and Cyclosporine
A Phase 1 study testing Mitomycin c in people with Pterygium, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Mitomycin c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery
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.
Read the detailed 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.
- Conditions
- Pterygium
- Being tested
- Mitomycin c
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin cDrug
Also called Cyclosporine
Comparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery
| Study group | Role | What they receive |
|---|---|---|
| mitomycine-C Group | Active comparator | 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. Receives: Drug: Mitomycin c |
| Cyclosporine Group | Active comparator | 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. Receives: Drug: Mitomycin c |
| artificial eye drops Group | Active comparator | 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. Receives: Drug: Mitomycin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 3 months after primary pterygium surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Jan 2021
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marwa Zaki, Assist.Prof., Study chair, Department of ophthalmology Faculty of Medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627947
- Sponsor's protocol ID
- OMNEYA HEGAZY
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Topical Mitomycin C and Cyclosporine After Primary Pterygium Surgery
- ClinicalTrials.gov ID
- NCT05627947
- Acronym / sponsor ID
- OMNEYA HEGAZY
- Conditions
- Pterygium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- compare the recurrence rates and complications associated with instillation of topical mitomycin C and cyclosporine after primary pterygium surgery
| Arm | Type | Receives |
|---|---|---|
| mitomycine-C Group | Active comparator | Drug: Mitomycin cThis 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. |
| Cyclosporine Group | Active comparator | Drug: Mitomycin cThis 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. |
| artificial eye drops Group | Active comparator | Drug: Mitomycin cThis is the Third Group and consists of !9 Patients and received artificial eye drops, 4 times per day for three months after the surgery. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin cAlso: CyclosporineComparing the effect of Mitomycin C versus Cyclosporine after primary pterygium surgery | Drug | Cyclosporine Group, artificial eye drops Group, mitomycine-C Group |
Primary outcome
Post Operative recurrence of pterygium
Time frame: from baseline to 3 months after primary pterygium surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Zaki, Assist.Prof. study chair
Department of ophthalmology Faculty of Medicine, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitomycin c in people with Pterygium, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative recurrence of pterygium (time frame: from baseline to 3 months after primary pterygium surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.