INJURE Study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Eye drops of interferon a-2b in post-surgical treatment of conjunctival intraepithelial neoplasia.

Secondary indentifying numbers:

IG/IAC/NIC/1101

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB).

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Reference number:

05-011-11-B (Procedure code), June 29, 2011.

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Clara Gómez Cabrera, MD. 2nd grade Specialist in Ophthalmology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Villa Clara, Universitary Hospital "Arnaldo Milian Castro", Ailyn del Carmen Cabrera Romero MD, 1st grade Specialist in Ophthalmology.

Research ethics committees:

Cuban Institute of Ophthalmology "Ramón Pando Ferrer", June 02, 2011. Universitary Hospital "Arnaldo Milian Castro", June 13, 2011.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

05/09/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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).

Key secondary outcomes:

- 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).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

75 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Odalys

Middle Name:

Caridad

Last Name:

Lazo Diago

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

odalys.lazo@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Francisco

Last Name:

Hernández Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.cu [3]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000119

Date of Registration in Primary Registry:

2011-07-11

Record Verification Date:

2011-06-30 20:00

Link to the spanish version:

Click here [4]