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Bevacizumab Treatment For Posterior Zone I ROP (ROP4)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634578
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : May 20, 2022
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Bevacizumab Phase 2

Detailed Description:
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bevacizumab Treatment For Posterior Zone I Retinopathy of Prematurity
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab- 0.063 mg
Participants will receive a single intravitreal injection of 0.063 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Drug: Bevacizumab

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Other Name: Avastin

Experimental: Bevacizumab- 0.25 mg
Participants will receive a single intravitreal injection of 0.25 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Drug: Bevacizumab

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Other Name: Avastin




Primary Outcome Measures :
  1. Treatment Success at 4 Weeks Post Injection [ Time Frame: 4 weeks ]

    Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria:

    • Improvement by the 4-day exam (3 to 5 days)
    • No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.



Information from the National Library of Medicine

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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:

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

  1. Birth weight < 1251 grams
  2. Newly diagnosed (within 2 days) type 1 ROP (as defined in section 2.4.2), with ROP and retinal vessels all in zone I, in one or both eyes
  3. Parent understands the protocol and is willing to provide consent.

If both eyes are eligible, then both are included. If one eye is eligible and the other eye has type 1 ROP with ROP or vessels in zone 2, then both eyes will receive the treatment randomly assigned. If one eye is eligible and the fellow eye later develops type 1 ROP within 4 weeks of injection in the first eye, then the fellow eye will also receive the treatment randomly assigned to the first eye and the fellow eye will follow the same 4-week post-injection study exam schedule, unless the first eye has already met failure criteria, in which case treatment and follow-up for the fellow eye is at investigator discretion.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will be excluded from study participation.

  1. Previous treatment for ROP
  2. Stage 4 or 5 ROP in either eye
  3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
  4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
  5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
  6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

  • Visually significant ocular anomaly (e.g., cataract, coloboma)
  • Opacity that precludes an adequate view of the retina

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): NCT04634578


Contacts
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Contact: Raymond T Kraker, MSPH 8139758690 rkraker@jaeb.org
Contact: Brooke P Fimbel 8139758690 bfimbel@jaeb.org

Locations
Show Show 36 study locations
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 Indiana University
  Study Documents (Full-Text)

Documents provided by Jaeb Center for Health Research:
Study Protocol  [PDF] June 21, 2021
Statistical Analysis Plan  [PDF] October 5, 2021
Informed Consent Form  [PDF] August 24, 2021

Additional Information:
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT04634578    
Other Study ID Numbers: ROP4
UG1EY011751 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
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 Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available after publication of each primary manuscript.
Access Criteria: Users accessing the data must enter an email address.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors