Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993043
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Lingkun Kong, Baylor College of Medicine

Tracking Information
First Submitted Date November 8, 2013
First Posted Date November 25, 2013
Last Update Posted Date September 1, 2020
Study Start Date October 2010
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2017)
Vision [ Time Frame: 5 years ]
Visual acuity will be measured at age of 3 and 5 years with HOTV card.
Original Primary Outcome Measures
 (submitted: November 20, 2013)
Vision [ Time Frame: 3 years ]
Visual acuity will be measured at age of 3 years with HOTV card.
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2017)
The changes of neurodevelopment outcome from birth to 5 years of age [ Time Frame: 1 to 5 years old ]
Neurodevelopmental assessments will be performed by board-certified, developmental-behavioral pediatric and neurodevelopmental disability pediatricians. Each neurodevelopmental assessment includes a developmental history, direct behavioral observations, and direct developmental testing using the Revised Gesell Developmental Schedules; the Motor Quotient will be used to assess gross motor development; and the Capute Scales will be used used to assess non-verbal, visual-motor problem-solving development and speech and language development.
Original Secondary Outcome Measures
 (submitted: November 20, 2013)
The changes of neurodevelopment outcome from birth to 3 years of age [ Time Frame: 1 and 3 years old ]
Neurodevelopmental assessments will be performed by board-certified, developmental-behavioral pediatric and neurodevelopmental disability pediatricians. Each neurodevelopmental assessment includes a developmental history, direct behavioral observations, and direct developmental testing using the Revised Gesell Developmental Schedules; the Motor Quotient will be used to assess gross motor development; and the Capute Scales will be used used to assess non-verbal, visual-motor problem-solving development and speech and language development.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
Official Title Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity
Brief Summary Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular endothelium growth factor (VEGF) is an important component of this disease. The goal of treatment is to reduce the production of VEGF in the immature retina and to eliminate the abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is important for the development of neurons and vessels in the systemic organs in premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm effects on ocular and systemic systems, especially neurological development. In this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to compare the short and long-term vision and neurodevelopmental outcomes of infants treated with IVB compared to laser ROP.
Detailed Description This study will enroll preterm infants who were scheduled to receive treatment for ROP by laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until 54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe short-term and long-term effects on visual system, brain and other body organs. Descriptive statistics from a two sample t-test or Fisher's exact test will be used to compare the short and long-term vision and neurological development outcomes. We predefined a statistical significance level p=0.05.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Premature infants
Condition Focus of the Study is to Evaluate the Efficacy and Safety of Bevacizumab for the Treatment of ROP
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 28, 2017)
150
Original Estimated Enrollment
 (submitted: November 20, 2013)
100
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I ROP .

Exclusion Criteria:

  1. Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
  2. Lack of signed consent by the parent or legal guardian.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Weeks to 40 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01993043
Other Study ID Numbers H-29628
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lingkun Kong, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Baylor College of Medicine
Verification Date August 2020