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Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Information source: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Conjunctival Intraepithelial Neoplasia; Corneal Intraepithelial Neoplasia

Intervention: Mitomycin C (Drug); Interferon Alfa-2b (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Coordinación de Investigación en Salud, Mexico

Official(s) and/or principal investigator(s):
Alvarado Beatriz, M.D., Principal Investigator, Affiliation: Instituto Mexicano del Seguro Social

Summary

The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.

Clinical Details

Official title: Clinical Trial to Compare Topical Interferon Alfa 2b And Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia

Secondary outcome: Adverse effects with topic therapy

Detailed description: The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b). Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined. Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with clinical diagnosis of corneal and conjunctival intraepithelial

neoplasia (CIN) with no history of ocular neoplasia Exclusion Criteria:

- Patients who did not agree to participate in the study.

- Patients with corneal abrasion

- Patients who have the diagnosis of CIN, but are pregnant

Locations and Contacts

IMSS Centro Médico de Occidente, Guadalajara, Jalisco, Mexico
Additional Information

Starting date: May 2014
Last updated: February 10, 2015

Page last updated: August 23, 2015

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