Systematic Approach for Children With Orbital Malformation With Sirolimus Use
Recruiting now · Phase 3
Conditions studied: Orbital Lymphatic Malformation
In brief
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: \[what is the safety of using sirolimus in patients with orbital lymphatic malformation\]? \[what is the efficacy of sirolimus in patients with orbital lymphatic malformation\]? Participants will be divided into three groups based on their symptoms, extent and type of orbital lymphatic malformation Group 1 ( will receive injection sclerotherapy): All Patients with symptomatic lymphatic malformation except those with complex malformation , Group 2 (will receive sirolimus on 0.8 mg per m2 twice daily for 6 months ):A) Patients with symptomatic complex lymphatic malformation. B) Patients in group 1 if there is progression in lesion size or ineffective local therapy Group 3 ( will receive both injection sclerotherapy and sirolimus):A) Patients in group 1 and patients with complex lymphatic malformation if there is concern for complications like hemorrhage, amblyopia and vision loss since diagnosis.
Key facts
- Study ID
- NCT07378657
- Run by
- Ain Shams University
- People needed
- 30
- Starts
- 2025-11-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-01-30
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age : 1-18 years Children and adolescents diagnosed with orbital low flow vascular malformation based on clinical , radilogical findings
You may not qualify if…
- Children and adolescents with orbital high flow vascular malformation
Where it is running
- Ain Shams University — Cairo, Cairo Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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