Back to resultsA Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Intravitreal Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Retinopathy of Prematurity
Eligibility Criteria
Inclusion Criteria: Infants with Type 1 ROP according to ETROP study which is defined as: 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 intravitreal injection Eyes with previous laser therapy Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
Sites / Locations
- Faculty of Medicine Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A recieved 0.3125mg intravitreal bevacizumab in both eyes
Group B received 0.625mg intravitreal bevacizumab in both eyes
Arm Description
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 .
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 .
Outcomes
Primary Outcome Measures
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
serum systemic VEGF measured using human VEGF ELISA kit
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.
Secondary Outcome Measures
Occurrence of any adverse events from intravitreal-injection
endophthalmitis , retinal detachment , cataract , vitreous hemorrhage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05712642
Brief Title
A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
Official Title
A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :
Serum Systemic VEGF levels. Retinal Vascularization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A recieved 0.3125mg intravitreal bevacizumab in both eyes
Arm Type
Experimental
Arm Description
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 .
Arm Title
Group B received 0.625mg intravitreal bevacizumab in both eyes
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Intravitreal Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Primary Outcome Measure Information:
Title
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
Description
serum systemic VEGF measured using human VEGF ELISA kit
Time Frame
at day 0 (baseline ) , 1 week and 4 weeks post-injection
Title
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
Description
Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.
Time Frame
"up to 60 weeks postmenstrual age"
Secondary Outcome Measure Information:
Title
Occurrence of any adverse events from intravitreal-injection
Description
endophthalmitis , retinal detachment , cataract , vitreous hemorrhage
Time Frame
Within 4 weeks from intravitreal injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with Type 1 ROP according to ETROP study which is defined as:
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 intravitreal injection
Eyes with previous laser therapy
Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nooran Abdelkader, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Cairo University
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
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