Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

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Brief Title

Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

Official Title

Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

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.
    


Study Type

Interventional


Primary Outcome

eye enucleation


Condition

Retinoblastoma

Intervention

photodynamic therapy

Study Arms / Comparison Groups

 PDT treatment 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

February 1, 2011

Completion Date

May 30, 2020

Primary Completion Date

May 30, 2018

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.
      

Gender

All

Ages

1 Year - 20 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04429139

Organization ID

2011MEKY0015


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

, , 


Verification Date

June 2020