A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
NCT ID: NCT05712642
Last Updated: 2023-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
19 participants
INTERVENTIONAL
2020-02-01
2021-01-28
Brief Summary
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Serum Systemic VEGF levels. Retinal Vascularization.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A recieved 0.3125mg intravitreal bevacizumab in both eyes
9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .
Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Group B received 0.625mg intravitreal bevacizumab in both eyes
10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .
Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Interventions
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Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Zone I ROP with plus disease
* Zone I, stage 3 ROP without plus disease
* Zone II, stage 2 or 3 ROP with plus disease
Exclusion Criteria
* Eyes with previous laser therapy
* Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
28 Weeks
40 Weeks
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Nooran Mohammed Abdelhameed Abdelkader
Assistant lecturer ophthalmology department Cairo university
Principal Investigators
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Nooran Abdelkader, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of Medicine Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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MD-108-2019
Identifier Type: -
Identifier Source: org_study_id
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