VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP

Sponsor
Universidad Autonoma de San Luis Potosí
Study ID
NCT03148132
Phase
PHASE4
Status
Completed

Conditions

  • Eye Diseases
  • Premature Birth
  • Retinal Disease
  • Retinopathy of Prematurity Both Eyes

Eligibility Criteria

Sex
ALL
Age
28 Days - 3 Months
Healthy Volunteers
Not accepted

Interventions

Study Details

The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina. The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP--\>ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --\> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus. The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.

Key Dates

First listed
May 10, 2017
Start date
May 23, 2017
Status verified
Jan 2019
Primary completion
Aug 30, 2018
Completion
Aug 30, 2018

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Bevacizumab injection
    Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis
  • Experimental: Ranibizumab Ophthalmic
    Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis

Primary Outcome Measure

To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab [ Time Frame: 6 months ]

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