INJURE Study
Phase 2
- Conditions
- Intraepithelial neoplasia of the conjunctiva.
- Registration Number
- RPCEC00000119
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
1) Histological diagnosis of intraepithelial neoplasia of the conjunctiva. 2) Age between 18 and 75, inclusive. 3) Voluntariness of the patient by signing the Informed Consent.
Exclusion Criteria
1) Patients who present at diagnosis, inflammatory and infectious eye diseases such as uveitis active, severe corneal ulcer and endophthalmitis. 2) bilateral tumor lesion of the ocular conjunctiva. 3) hypersensitivity to IFN or other component of the formulation. 4) antiviral treatment (including IFN via any route) in the last 30 days. 5) Pregnancy or lactation at the time of inclusion in the study. 6) Mental incapacity to give consent clearly and act accordingly to the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Tumor recurrence (defined as the appearance of tumorous lesion in the first year post-surgery [if it occurs in the first 6 months is considered early recurrence, after 6 months, late recurrence]). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months).
- Secondary Outcome Measures
Name Time Method - Time to recurrence (days, months). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Occurrence of complications (Yes, No, type, severity, causal relationship to study treatment). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months). - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: Weekly (1st month of surgery), monthly (2nd and 3rd month post-surgery), quarterly through the year (6, 9 and 12 months).