A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Study Overview
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Brief Summary
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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.

Official Title
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A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Drug: Intravitreal Bevacizumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A recieved 0.3125mg intravitreal bevacizumab in both eyes<br>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 . | Drug: Intravitreal Bevacizumab<br>* Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab<br>* Other names: Avastin;|
| Active Comparator: Group B received 0.625mg intravitreal bevacizumab in both eyes<br>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 . | Drug: Intravitreal Bevacizumab<br>* Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at day 0 (baseline ) , 1 week and 4 weeks post-injection | 
| 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. | up to 60 weeks postmenstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any adverse events from intravitreal-injection | endophthalmitis , retinal detachment , cataract , vitreous hemorrhage | Within 4 weeks from intravitreal injection |