Back to resultsPhotodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Primary Purpose
Retinoblastoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring Photodynamic therapy, Retinoblastoma, Visudyne, Verteporfin
Eligibility Criteria
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.
Sites / Locations
- Kunbei Lai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PDT treatment group
Arm 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.
Outcomes
Primary Outcome Measures
eye enucleation
the rate of eye enucleation of patients with retinoblastoma in different groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429139
Brief Title
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Official Title
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2011 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
Photodynamic therapy, Retinoblastoma, Visudyne, Verteporfin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDT treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
photodynamic therapy
Other Intervention Name(s)
systemic chemotherapy, Laser photocoagulation, Cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
eye enucleation
Description
the rate of eye enucleation of patients with retinoblastoma in different groups
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Kunbei Lai
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
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