Systematic Approach for Children With Orbital Malformation With Sirolimus Use
Recruiting
Phase 3
Interventional Study
Orbital Lymphatic Malformation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Ain Shams University · Other
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About This Trial
The goal of this interventional study is to Set a systematic management approach for orbital lymphatic malformation and to study the safety and efficacy of sirolimus in children and adolescents with orbital lymphatic malformation\]. The main questions it aims to answer are:
\[what is the safety of using sirolimus in patients with orbital lymphatic malformation\]? \[what is the efficacy of sirolim…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Age : 1-18 years Children and adolescents diagnosed with orbital low flow vascular malformation based on clinical , radilogical findings
Exclusion Criteria:
Children and adolescents with orbital high flow vascular malformation
Contacts