Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

NCT04429139 | Completed DMC

• 1 other identifier: 2011MEKY0015
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinoblastoma

Keywords

Photodynamic therapy; Retinoblastoma; Visudyne; Verteporfin

Outcome Measures

Primary Outcomes (1)

• eye enucleation

  the rate of eye enucleation of patients with retinoblastoma in different groups

  3 years

Study Arms (1)

PDT treatment group

EXPERIMENTAL

All the patients received once PDT with Visudyne® as the initial treatment. Rescue treatment with systemic chemotherapy would be given to patients if tumors were insensitive to PDT treatment, the tumors became larger, or disease relapse.

Drug: photodynamic therapy

Interventions

photodynamic therapy DRUG

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.

Also known as: systemic chemotherapy, Laser photocoagulation, Cryotherapy

PDT treatment group

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with intraocular retinoblastoma of Group A-D

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Kunbei Lai

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Retinoblastoma

Interventions

Photochemotherapy; Neoadjuvant Therapy; Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: February 1, 2011
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)