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39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT01993043
Recruitment Status : Unknown
Verified January 2017 by Lingkun Kong, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lingkun Kong, Baylor College of Medicine

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.

Condition or disease
Focus of the Study is to Evaluate the Efficacy and Safety of Bevacizumab for the Treatment of 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity
Study Start Date : October 2010
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018





Primary Outcome Measures :
  1. Vision [ Time Frame: 5 years ]
    Visual acuity will be measured at age of 3 and 5 years with HOTV card.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   30 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Premature infants
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993043


Contacts
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Contact: Lingkun Kong, MD, Ph.D 832-8223222 lxxkong@gmail.com
Contact: Paul G Steinkuller, MD 832-8223234 pgsteinkullers@gmail.com

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Lingkun Kong, MD, Ph.D    832-822-3222    lxxkong@gmail.com   
Contact: Paul Steinkuller, MD    832-8223234    pgsteinkuller@gmail.com   
Sub-Investigator: Lingkun Kong, MD, Ph.D         
Sub-Investigator: Amit Bhatt, MD         
Sub-Investigator: Paul G Steinkuller, MD         
Sponsors and Collaborators
Baylor College of Medicine

Additional Information:

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Responsible Party: Lingkun Kong, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01993043     History of Changes
Other Study ID Numbers: H-29628
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: January 2017

Keywords provided by Lingkun Kong, Baylor College of Medicine:
ROP
Bevacizumab
Laser
Development

Additional relevant MeSH terms:
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Retinopathy of Prematurity
Retinal Diseases
Infant, Premature, Diseases
Eye Diseases
Infant, Newborn, Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors