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Trial record 13 of 293 for:    retinopathy of prematurity

Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity (ROP1)

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ClinicalTrials.gov Identifier: NCT02390531
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Bevacizumab Phase 1

Detailed Description:
Despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe ROP, little is known about lower doses of bevacizumab for ROP. An increasing number of ophthalmologists are treating premature infants with severe ROP using bevacizumab. Given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. The proposed study will test progressively lower doses to find a dose to take forward to a future larger study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Actual Study Start Date : April 28, 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab
Dosage if injected Bevacizumab to be studied
Drug: Bevacizumab
Varying dosages in 10µl
Other Name: Avastin




Primary Outcome Measures :
  1. Successful Treatment of ROP [ Time Frame: 4 weeks post-injection ]

    Success is defined as improvement* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.

    * For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity.

    A dose will be considered effective if it successfully treats at least 80% of subjects.



Secondary Outcome Measures :
  1. Distribution of VEGF Levels [ Time Frame: 2 weeks post-injection ]
    The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of vascular endothelial growth factor (VEGF) and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.

  2. Distribution of VEGF Levels [ Time Frame: 4 weeks post-injection ]
    The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.

  3. Distribution of Avastin Levels [ Time Frame: 2 weeks post-injection ]
    The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.

  4. Distribution of Avastin Levels [ Time Frame: 4 weeks post-injection ]
    The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.

  5. Number of study eye and fellow eyes requiring additional treatment/s for ROP, and if retreated, type of treatment [ Time Frame: 12-month corrected age ]
    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months

  6. Any adverse events or complications since the 4-week exam [ Time Frame: 12-month corrected age ]
    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months

  7. Assessment of vision [ Time Frame: 12-month corrected age ]
    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months

  8. Proportion of infants for whom at least one event was reported [ Time Frame: Enrollment to 12-month corrected age ]

    Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method

    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months


  9. Proportion of infants with an adverse event thought by investigator to be related to study drug [ Time Frame: Enrollment to 12-month corrected age ]

    Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method

    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months


  10. Proportion of infants for whom at least one serious adverse event was reported [ Time Frame: Enrollment to 12-month corrected age ]
    Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method

  11. Proportion of infant deaths [ Time Frame: Enrollment to 12-month corrected age ]

    Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method

    12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months


  12. 24-Month Extended Follow Up Exam [ Time Frame: 24-month corrected age ]

    A subset of infants enrolled in ROP1 will have extended follow up consisting of one additional office exam with developmental testing.

    This testing will provide a cross-sectional evaluation of visual acuity, refractive error, and development at the adjusted age 24-month visit.

    24-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 24 months.




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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 1 ROP; defined as:

    • Zone I, any stage ROP with plus disease, or
    • Zone I, stage 3 ROP without plus disease, or
    • Zone II, stage 2 or 3 ROP with plus disease
  2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

Exclusion Criteria:

The following exclusions apply to the study eye:

  1. Nasolacrimal duct obstruction
  2. Major ocular anomalies (e.g., cataract, coloboma)
  3. Any opacity that precludes an adequate view of the retina

If purulent ocular discharge is present in either eye, then the infant is ineligible.


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): NCT02390531


Contacts
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Contact: Raymond Kraker, MSPH 813-975-8690 rkraker@jaeb.org
Contact: Jennifer Shah 813-975-8690 pedig@jaeb.org

Locations
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United States, Georgia
The Emory Eye Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Amy Hutchinson, MD    404-778-4725    amy.hutchinson@emory.edu   
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathryn Haider, MD    317-274-1214    khaider@iupui.edu   
United States, Maryland
Wilmer Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michael Repka, MD    410-955-8314    mrepka@jhmi.edu   
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Deborah VanderVeen, MD    617-355-6401    deborah.vanderveen@childrens.harvard.edu   
United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27710
Sub-Investigator: David K. Wallace, M.D.         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michael Yang, MD    513-636-4751    Michael.Yang@cchmc.org   
Pediatric Ophthalmology Associates, Inc. Recruiting
Columbus, Ohio, United States, 43205
Contact: David Rogers, MD    614-224-6222    david.rogers@nationwidechildrens.org   
United States, Oklahoma
Dean A. McGee Eye Institute, University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: R. Michael Siatkowski, MD    405-271-1094    rmichael-siatkowski@dmei.org   
United States, Texas
Texas Children's Hospital - Dept. Of Ophthalmology Recruiting
Houston, Texas, United States, 77030
Contact: Amit Bhatt, MD    832-822-3230    arbhatt@texaschildrens.org   
Contact: David Coats, MD    (832) 822-3230    dcoats@bcm.tmc.edu   
United States, Utah
University of Utah Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: M E Hartnett, MD    801-581-2352    ME.Hartnett@hsc.utah.edu   
United States, Virginia
Virginia Pediatric Eye Center Recruiting
Norfolk, Virginia, United States, 23502
Contact: Eric Crouch, MD    757-461-0050    ercrouch@gmail.com   
Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
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Study Chair: David K Wallace, MD, MPH Duke Eye Center

Additional Information:
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02390531     History of Changes
Other Study ID Numbers: ROP1
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Time Frame: Data will be made available after publication of each primary manuscript.
Access Criteria: Users accessing the data must enter an email address.

Keywords provided by Jaeb Center for Health Research:
Retinopathy of Prematurity
Bevacizumab
ROP

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