A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Retinopathy of Prematurity

Treatments: Drug: Intravitreal Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05712642

MD-108-2019

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 28 to 40 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Group A recieved 0.3125mg intravitreal bevacizumab in both eyes

Experimental group

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 .

Treatment:

Drug: Intravitreal Bevacizumab

Group B received 0.625mg intravitreal bevacizumab in both eyes

Active Comparator group

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 .

Treatment:

Drug: Intravitreal Bevacizumab