Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

Retinoblastoma Clinical Trial

Official title:

Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429139
• Other study ID #: 2011MEKY0015
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Description:

Retinoblastoma is the commonest primary intraocular malignancy in infancy and early childhood. Ophthalmologist are trying to seek other more safe and effective treatment modalities to well control the tumor and preserve the visual function. Photodynamic therapy (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated. In this study, we are gonging to investigate the the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

Inclusion Criteria:

• patients with intraocular retinoblastoma of Group A-D

Exclusion Criteria:

• (1) patients with intraocular retinoblastoma of group E; (2) patients with extraocular spread; (3); media opacities such as corneal opacity, significant cataract, or vitreous hemorrhage obscuring fundus examination; (4) patients who were allergic to verteporfin or other benzoporphyrin derivatives.

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• photodynamic therapy
PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.

Locations

Country	Name	City	State
China	Kunbei Lai	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eye enucleation	the rate of eye enucleation of patients with retinoblastoma in different groups	3 years