Retinopathy of Prematurity
Conditions
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.
Interventions
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 40 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups. | at day 0 (baseline ) , 1 week and 4 weeks post-injection | 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. | up to 60 weeks postmenstrual age | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of any adverse events from intravitreal-injection | Within 4 weeks from intravitreal injection | endophthalmitis , retinal detachment , cataract , vitreous hemorrhage |
Countries
Egypt
Outcome results
None listed