A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Sponsor
Cairo University
Study ID
NCT05712642
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
28 Weeks - 40 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Bevacizumab — DRUG
    Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Study Details

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.

Key Dates

First listed
Feb 3, 2023
Start date
Feb 1, 2020
Status verified
Feb 2023
Primary completion
Dec 30, 2020
Completion
Jan 28, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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 .
  • Active Comparator: 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 .

Primary Outcome Measure

Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups. [ Time Frame: at day 0 (baseline ) , 1 week and 4 weeks post-injection ]

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