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CompletedNCT04429139Updated Jun 12, 2020

Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

An interventional study of photodynamic therapy in Retinoblastoma, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 1 Year to 20 Years. Per ClinicalTrials.gov, last updated 2020-06-12.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 years 4 months after the study started (first participant enrolled Feb 2011, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
1 Year to 20 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Retinoblastoma

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Keywords

  • Photodynamic therapy
  • Retinoblastoma
  • Visudyne
  • Verteporfin
03

In context

Retinoblastoma

124 studies on the registry are indexed under Retinoblastoma; 23 are open to participants now.

This study's enrollment of 8 is below the median of 29 across 78 interventional studies indexed under Retinoblastoma.

Browse Retinoblastoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with intraocular retinoblastoma of Group A-D

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    PDT treatment group

    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

  • Drugphotodynamic 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.

    Also known as: systemic chemotherapy, Laser photocoagulation, Cryotherapy

06

What researchers measure

Primary outcomes

  1. eye enucleation

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

    Time frame: 3 years

07

Study locations

1 site
  • Kunbei Lai
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04429139
Lead sponsor
Sun Yat-sen University
Responsible party
Jin Chen-jin (Prof., Sun Yat-sen University) — Principal investigator
First posted
Jun 12, 2020
Start date
Feb 1, 2011
Primary completion
May 30, 2018
Completion
May 30, 2020
Last update
Jun 12, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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