INJURE Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000119
• Date of registration: 11/07/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: INJURE Study
• Scientific title: Eye drops of interferon a-2b in post-surgical treatment of conjunctival intraepithelial neoplasia.
• Date of first enrolment: 05/09/2011
• Target sample size: 68
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000119-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Dr. Francisco Hernández Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Odalys Lazo Diago
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

Intraepithelial neoplasia of the conjunctiva.

Intervention(s)

Group I (study): Administration of recombinant interferon eye drops, by topical route (ocular), one drop (in the operated eye) every 4 hours for 30 days. Group II (control): Administration of placebo eye drops, by topical route (ocular), one drop (in the operated eye) every 4 hours for 30 days.

Primary Outcome(s)

- 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(s)

- 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).

Secondary ID(s)

IG/IAC/NIC/1101

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB).

Secondary Sponsor(s)

Not aplicable.