Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy

Retinopathy Clinical Trial

— CARI2b  

Official title:

Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy in Patients With Melanomas of the Skin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02702973
• Other study ID #: 2016WD2M1
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 8, 2016
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2016
• Source: First Hospital of Jilin University
• Contact: Di Wu, doctor
• Phone: +86-139-4488-8991
• Email: wudi888991[@]163.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced retinopathy, especially in the patients with hypertension or diabetes, so these patients should be followed up after treatment.

Description:

Patients with melanomas of the skin whose tumors have been resected completely were collected. The detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. Fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Men and women, at least 18 years of age.

2. ECOG performance status 0 or 1.

3. Patients must have histologically confirmed stage IB to stage III primary melanoma of cutaneous origin (AJCC 7th edition classification).

4. Must complete all primary therapy (wide excision with or without lymphadenectomy).

Exclusion Criteria:

1. Mucous membrane or ocular melanoma.

2. Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening).

3. Patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy.

4. History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).

5. Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.

6. Patients who have a history of depression or other psychiatric diseases requiring hospitalisation.

7. History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes),

8. Unwilling or unable to comply with the requirements of the protocol for the duration of the study.

Study Design

Observational Model: Case-Crossover

Related Conditions & MeSH terms

• Retinal Diseases
• Retinopathy

Intervention

Other:
• Observe the fundus characteristics after therapy.

Locations

Country	Name	City	State
China	Jilin University,No.1 Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ocular fundus after high doses of interferon a-2b therapy at the 1st week.		the 1st week	No