Last updated: July 27, 2021
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Overall Status: Active - Recruiting
Phase
2
Condition
Retinoblastoma
Treatment
N/AClinical Study ID
NCT04990271
V2.3
Ages 3-5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The patient's guardian signs an informed consent form and is willing to receivefollow-up according to the schedule of the trial;
- Children of more than 3 months and under 5 years of age who have not received anyanti-cancer treatment;
- The target eye must meet the following requirements: Clinically diagnosed as monocular retinoblastoma; According to the IIRC diagnosticcriteria, the treatment eye is classified as Group E stage without clinical high-riskfactors (Table 1); No refractive medium turbidity and/or pupillary abnormalities thataffect the fundus examination; IOP≤21mmHg.
- Sufficient organ function at baseline.
Exclusion
Exclusion Criteria: Subjects with any of the following eye conditions:
- Patients diagnosed as stage E retinoblastoma in one eye, but with high-risk factors:neovascular glaucoma; refractive interstitial opacity caused by anterior chamber,vitreous or subretinal hemorrhage; tumor invasion of optic nerve posterior to thecribriform plate and choroid (range of diameter> 2 mm), sclera, and anterior chamber;
- Treatment-naïve pediatric patients; Patients with any of the following systemic diseases:
- With a history of allergies or have allergic reactions to fluorescein sodium, with ahistory of allergies to protein products for treatment or diagnosis, and have allergicreactions to two or more drugs and/or non-drug factors, or suffering from allergicdiseases;
- Low birth weight children, and severely growth-stunted children;
- Children who need systemic treatment for other system diseases;
- Any condition that should be excluded from the study in the opinion of theinvestigator.
Study Design
Total Participants: 92
Study Start date:
July 05, 2021
Estimated Completion Date:
July 15, 2023
Connect with a study center
Beijing Children's Hospital
Beijing, Beijing
ChinaSite Not Available
Henan Children's Hospital
Zhengzhou, Henan
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
The Second Xiangya Hospital Of Central South University
Changsha, Hunan
ChinaSite Not Available
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai
ChinaActive - Recruiting
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