RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

Study Overview
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Brief Summary
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Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon technique , another is selective ophthalmic artery infusion.This study evaluates the difference of Ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. Half of participants will receive, Ballon technique while the other half will receive selective ophthalmic artery infusion

Detailed Description
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Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Two alternative means can be used,The purpose of this study is to show that Ballon technique and SOAI delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.

Official Title
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RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients

Conditions
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Retinoblastoma, IAC, Selective Ophthalmic Artery Infusion, Ballon Technique

Intervention / Treatment
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* Device: Ballon Technique
* Device: SOAI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No age limit, no gender limit, monocular or binocular affected; New diagnosed cases, without any previous treatment; Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated; Normal bone marrow function Normal liver function Normal kidney function Normal coagulation function To be willing to take part in the clinical trial and sign the informed consent form; 9. To be willing to have these tumor sites surgically removed and do the follow up accordingly. Exclusion Criteria: Diagnosis is not clear; With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization); With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia; Took part in other clinical study within 3 months; Refuse to take part in this clinical study; Is not willing to do the follow up accordingly or follow up less than 2 times.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ballon Technique group<br>Intervention：Ballon Technique | Device: Ballon Technique<br>* Ballon Technique<br>|
| Active Comparator: SOAI group<br>Intervention：Selective Ophthalmic Artery Infusion | Device: SOAI<br>* SOAI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Globe salvage rate (Eyes saved/Eyes treated) | Event defined as the need for external beam enucleation，To assess the saving of eyes affected with IAC for patients who would have been candidates for enucleation | Three years from intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual pathway function | Evaluation of visual pathway function will be measured composite using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging | Three years from intervention | 
| complications | Short and long term complications | Three years from intervention |