Retinopathy of PrematurityPhase 2ROP4NCT04634578
Bevacizumab Treatment For Type 1 ROP
A Phase 2 study testing Bevacizumab in people with Retinopathy of Prematurity, run by Jaeb Center for Health Research at 26 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 1 May 2022to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:
- Birth weight < 1251 grams
- Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
Who cannot join
- Participants meeting any of the following exclusion criteria will be excluded from study participation.
- Previous treatment for ROP
- Stage 4 or 5 ROP in either eye
- Treatment could not be done within 2 days of diagnosis of type 1 ROP
- Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
- 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.
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- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
The Emory Eye Center
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809
Boston Children's Hospital
Boston, Massachusetts, 02215
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
U of Illinois at Chicago Eye and Ear Infirmary
Chicago, Illinois, 60612
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205
Duke University Eye Center
Durham, North Carolina, 27710
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030
University of Chicago
Hyde Park, Illinois, 60637
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697
UK Ophthalmology and Visual Sciences, The Eye Clinic
Lexington, Kentucky, 40508
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
Little Rock, Arkansas, 72202
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, 90095
Storm Eye Institute
Mt. Pleasant, South Carolina, 29464
New York Presbyterian David H Koch Center
New York, New York, 10065
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Casey Eye Institute
Portland, Oregon, 97239
University of California, Davis
Sacramento, California, 95817
University of Utah Moran Eye Center
Salt Lake City, Utah, 84132
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143
About this study
Official title: Bevacizumab Treatment For Type 1 Retinopathy of Prematurity
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.
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Bevacizumab
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
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.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab- 0.063 mg | Experimental | 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. Receives: Drug: Bevacizumab |
| Bevacizumab- 0.25 mg | Experimental | 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success at 4 Weeks Post Injection
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 May 2022
- Primary completion1 Jul 2025
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- David K Wallace, MD, MPH, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634578
- Sponsor's protocol ID
- ROP4
- Other IDs
- UG1EY011751
- Acronym
- ROP4
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2020
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Treatment For Type 1 Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT04634578
- Acronym / sponsor ID
- ROP4 / ROP4
- Conditions
- Retinopathy of Prematurity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab- 0.063 mg | Experimental | Drug: BevacizumabParticipants 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. |
| Bevacizumab- 0.25 mg | Experimental | Drug: BevacizumabParticipants 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:
- Birth weight < 1251 grams
- Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
Key exclusion criteria (10 listed)
- Participants meeting any of the following exclusion criteria will be excluded from study participation.
- Previous treatment for ROP
- Stage 4 or 5 ROP in either eye
- Treatment could not be done within 2 days of diagnosis of type 1 ROP
- Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinAll 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. | Drug | Bevacizumab- 0.063 mg, Bevacizumab- 0.25 mg |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- PEDIG Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David K Wallace, MD, MPH study chair
Vanderbilt University
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Retinopathy of Prematurity, run by Jaeb Center for Health Research at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success at 4 Weeks Post Injection (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.