NCT02090322

Brief Summary

The Retinopathy of Prematurity (ROP) is a Retina's pathology only of the premature baby, it's characterized for proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina. The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of the principal factor in the pathogenesis of the ROP. The ROP is classified for: location (zones I,II,III), extension (hours 1 to 12) and for stages (1,2,3,4a,4b,5) and features of the vessels (normal, pre-plus and plus). With the diagnosis of ROP type 1(ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus) the treatment is begun and ROP type 2 is maintained in observation. The altered regulation of Vascular Endothelial Grow Factor (VEGF) has been proposed as one of the principal factors in the pathogenesis of ROP.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

February 20, 2014

Last Update Submit

March 17, 2014

Conditions

Retinopathy of Prematurity

Keywords

ROPBevacizumabNo inferiority

Outcome Measures

Primary Outcomes (1)

  • Regression of Retinopathy of prematurity

    Injection of bevacizumab and regression of this

    4 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL

The treatment for Retinopathy of prematurity is Intravitreal bevacizumab. We want to compare two dosages (0.500 and 0.625mg) and demonstrate that 0.500mg there isn't lower in efficacy than 0.625mg. When the baby have the diagnosis or Retinopathy of prematurity we are going to inyect the eye that have te problem, then we are going to explore until this illness disappear. It is only one intervention

Procedure: Injection of bevacizumab intravitreal (Avastin)

Interventions

Injection of bevacizumab intravitreal (Avastin)PROCEDURE

The treatment of Retinopathy of prematurity is with bevacizumab intravitreal for resolution of the illness. When there is a Retinopathy of prematurity type 1, is the indication for the infection

Also known as: Antiangiogenic, Avastin
Bevacizumab

Eligibility Criteria

Age1 Month - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Prematurity, low weight, oxygen, retinopathy of prematurity type 1

You may not qualify if:

  • Retinopathy of prematurity type 2, retinopathy of prematurity stage 4 or 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Central Dr. "IMP"

Mexico, San Luis Potosí, 78240, Mexico

RECRUITING

Hospital Central Dr."IMP"

Mexico, San Luis Potosí, Mexico

RECRUITING

Hospital Central Dr."IMP"

Mexico, San Luis Potosí, Mexico

RECRUITING

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

BevacizumabAngiogenesis Inhibitors

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAngiogenesis Modulating AgentsGrowth SubstancesPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGrowth InhibitorsAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Rangel Ch Martha, Speciality

    Universidad Autonoma de San Luis Potosí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dra.Martha Giselda Rangel Charqueño

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 18, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

ME(3)