Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

Sun Yat-sen University

Status: Completed

Conditions: Retinoblastoma

Treatments: Drug: photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04429139

2011MEKY0015

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

PDT treatment group

Experimental group

Description:

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.

Treatment:

Drug: photodynamic therapy