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Study identifier: NCT07378657 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Systematic Approach for Children With Orbital Malformation With Sirolimus Use

Condition: Orbital Lymphatic Malformation  ·  Sponsor: Ain Shams University

PhasePhase 3
Planned participants30
Who can joinAll sexes, 1 Year to 18 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

nihal hussien aly mostafa  ·  +201001053961  ·  nihal.hussien.ali@gmail.com

iman ahmed ragab  ·  +201002550680  ·  hragab68@hotmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Ain Shams UniversityCairo, Cairo Governorate, EgyptRecruiting

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Source record: clinicaltrials.gov/study/NCT07378657