Actively Recruiting

Phase 3
Age: 1Year - 18Years
All Genders
NCT07378657

Systematic Approach for Children With Orbital Malformation With Sirolimus Use

Led by Ain Shams University · Updated on 2026-01-30

30

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Systematic Approach for Children With Orbital Malformation With Sirolimus Use

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 1 to 18 years
  • Children and adolescents diagnosed with orbital low flow vascular malformation based on clinical and radiological findings
Not Eligible

You will not qualify if you...

  • Children and adolescents with orbital high flow vascular malformation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Cairo Governorate, Egypt, 11321

Actively Recruiting

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Research Team

N

nihal hussien aly mostafa

CONTACT

I

iman ahmed ragab

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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