- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429139
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
June 10, 2020 updated by: Jin Chen-jin, Sun Yat-sen University
To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510000
- Kunbei Lai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
eye enucleation
Time Frame: 3 years
|
the rate of eye enucleation of patients with retinoblastoma in different groups
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2011
Primary Completion (Actual)
May 30, 2018
Study Completion (Actual)
May 30, 2020
Study Registration Dates
First Submitted
June 10, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 12, 2020
Study Record Updates
Last Update Posted (Actual)
June 12, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Eye Neoplasms
- Retinal Neoplasms
- Retinoblastoma
Other Study ID Numbers
- 2011MEKY0015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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