Retinopathy of PrematurityPhase 1ROP1NCT02390531
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
A Phase 1 study testing Bevacizumab in people with Retinopathy of Prematurity, run by Jaeb Center for Health Research at 11 sites in United States.
Trial 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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Apr 2015to 11 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
- No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye
Who cannot join
- The following exclusions apply to the study eye:
- Nasolacrimal duct obstruction
- Major ocular anomalies (e.g., cataract, coloboma)
- Any opacity that precludes an adequate view of the retina
- If purulent ocular discharge is present in either eye, then the infant is ineligible.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The Emory Eye Center
Atlanta, Georgia, 30322
Wilmer Institute
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
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
Riley Hospital for Children
Indianapolis, Indiana, 46202
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Utah Moran Eye Center
Salt Lake City, Utah, 84132
About this study
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.
Read the 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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Bevacizumab
- Keywords
- Retinopathy of Prematurity, Bevacizumab, ROP
- 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
Varying dosages in 10µl
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab 0.250 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.125 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.063 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.031 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.016 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.008 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.004 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
| Bevacizumab 0.002 mg | Experimental | Dosage of injected Bevacizumab to be studied Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Treatment of ROP
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.
Measured: 4 weeks post-injection
Secondary outcomes (13)
Distribution of VEGF Levels
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.
Measured: 2 weeks post-injection
Distribution of VEGF Levels
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.
Measured: 4 weeks post-injection
Distribution of Avastin Levels
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.
Measured: 2 weeks post-injection
Distribution of Avastin Levels
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.
Measured: 4 weeks post-injection
Number of Study Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Measured: 12-month corrected age
Any Adverse Events or Complications Since the 4-week Exam
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Measured: 12-month corrected age
Visual Fixation Status at 12 Months
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Measured: 12-month corrected age
Proportion of Infants for Whom at Least One Event Was Reported
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
Measured: Enrollment to 12-month corrected age
Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug
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
Measured: Enrollment to 12-month corrected age
Count of Infants for Whom at Least One Serious Adverse Event Was Reported
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.
Measured: Enrollment to 12-month corrected age
Number of Infant Deaths
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Measured: Enrollment to 12-month corrected age
Number of Infants With 24-Month Extended Follow Up Exam
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.
Measured: 24-month corrected age
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Measured: 12-month corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start28 Apr 2015
- Primary completion4 Jun 2019
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 8 bevacizumab doses were evaluated in this dose de-escalation study in the following dosage amounts: 0.250mg, 0.125mg, 0.063mg, 0.031mg, 0.016mg, 0.008mg, 0.004mg, 0.002mg. Each dose was planned to be used in up to 14 infants to ensure at least 10 infants with 4-week outcomes
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390531
- Sponsor's protocol ID
- ROP1
- Other IDs
- 2U10EY011751
- Acronym
- ROP1
- Status last verified
- Nov 2022
- First submitted
- 17 Feb 2015
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Wallace DK, Kraker RT, Freedman SF, Crouch ER, Hutchinson AK, Bhatt AR, Rogers DL, Yang MB, Haider KM, VanderVeen DK, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Hartnett ME, Kong L, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Assessment of Lower Doses of Intravitreous Bevacizumab for Retinopathy of Prematurity: A Phase 1 Dosing Study. JAMA Ophthalmol. 2017 Jun 1;135(6):654-656. doi: 10.1001/jamaophthalmol.2017.1055.
PubMed 28448664Kraker RT, Wallace DK, Beck RW, Saunders CT, Lorenzi E, Melia BM, Li Z; Pediatric Eye Disease Investigator Group. Choice of Dose Level for a Randomized Clinical Trial of Low-Dose Bevacizumab vs Laser for Type 1 Retinopathy of Prematurity. JAMA Ophthalmol. 2021 Oct 1;139(10):1143-1144. doi: 10.1001/jamaophthalmol.2021.3192.
PubMed 34410311Wallace DK, Dean TW, Hartnett ME, Kong L, Smith LE, Hubbard GB, McGregor ML, Jordan CO, Mantagos IS, Bell EF, Kraker RT; Pediatric Eye Disease Investigator Group. A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments. Ophthalmology. 2018 Dec;125(12):1961-1966. doi: 10.1016/j.ophtha.2018.05.001. Epub 2018 Jun 7.
PubMed 29887334Crouch ER, Kraker RT, Wallace DK, Holmes JM, Repka MX, Collinge JE, Bremer DL, Gray ME, Smith HA, Steinkuller PG; Writing Committee for Pediatric Eye Disease Investigator Group. Secondary 12-Month Ocular Outcomes of a Phase 1 Dosing Study of Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jan 1;138(1):14-20. doi: 10.1001/jamaophthalmol.2019.4488.
PubMed 31697304Wallace DK, Kraker RT, Freedman SF, Crouch ER, Bhatt AR, Hartnett ME, Yang MB, Rogers DL, Hutchinson AK, VanderVeen DK, Haider KM, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Kong L, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jun 1;138(6):698-701. doi: 10.1001/jamaophthalmol.2020.0334.
PubMed 32324197
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT02390531
- Acronym / sponsor ID
- ROP1 / ROP1
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of Prematurity, Bevacizumab, ROP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- 8 bevacizumab doses were evaluated in this dose de-escalation study in the following dosage amounts: 0.250mg, 0.125mg, 0.063mg, 0.031mg, 0.016mg, 0.008mg, 0.004mg, 0.002mg. Each dose was planned to be used in up to 14 infants to ensure at least 10 infants with 4-week outcomes
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab 0.250 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.125 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.063 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.031 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.016 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.008 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.004 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
| Bevacizumab 0.002 mg | Experimental | Drug: BevacizumabDosage of injected Bevacizumab to be studied |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Type 1 ROP; defined as:
- No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye
Key exclusion criteria (5 listed)
- Nasolacrimal duct obstruction
- Major ocular anomalies (e.g., cataract, coloboma)
- Any opacity that precludes an adequate view of the retina
- If purulent ocular discharge is present in either eye, then the infant is ineligible.
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: AvastinVarying dosages in 10µl | Drug | Bevacizumab 0.002 mg, Bevacizumab 0.004 mg, Bevacizumab 0.008 mg, Bevacizumab 0.016 mg, Bevacizumab 0.031 mg, Bevacizumab 0.063 mg, Bevacizumab 0.125 mg, Bevacizumab 0.250 mg |
Primary outcome
Number of Participants With 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.
13 secondary outcomes
Distribution of VEGF Levels
Time frame: 2 weeks post-injection
Distribution of VEGF Levels
Time frame: 4 weeks post-injection
Distribution of Avastin Levels
Time frame: 2 weeks post-injection
Distribution of Avastin Levels
Time frame: 4 weeks post-injection
Number of Study Eyes Requiring Additional Treatment/s for ROP
Time frame: 12-month corrected age
Any Adverse Events or Complications Since the 4-week Exam
Time frame: 12-month corrected age
Visual Fixation Status at 12 Months
Time frame: 12-month corrected age
Proportion of Infants for Whom at Least One Event Was Reported
Time frame: Enrollment to 12-month corrected age
Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug
Time frame: Enrollment to 12-month corrected age
Count of Infants for Whom at Least One Serious Adverse Event Was Reported
Time frame: Enrollment to 12-month corrected age
Number of Infant Deaths
Time frame: Enrollment to 12-month corrected age
Number of Infants With 24-Month Extended Follow Up Exam
Time frame: 24-month corrected age
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
Time frame: 12-month corrected age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28448664Wallace DK, Kraker RT, Freedman SF, Crouch ER, Hutchinson AK, Bhatt AR, Rogers DL, Yang MB, Haider KM, VanderVeen DK, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Hartnett ME, Kong L, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Assessment of Lower Doses of Intravitreous Bevacizumab for Retinopathy of Prematurity: A Phase 1 Dosing Study. JAMA Ophthalmol. 2017 Jun 1;135(6):654-656. doi: 10.1001/jamaophthalmol.2017.1055.
- Background: PubMed 34410311Kraker RT, Wallace DK, Beck RW, Saunders CT, Lorenzi E, Melia BM, Li Z; Pediatric Eye Disease Investigator Group. Choice of Dose Level for a Randomized Clinical Trial of Low-Dose Bevacizumab vs Laser for Type 1 Retinopathy of Prematurity. JAMA Ophthalmol. 2021 Oct 1;139(10):1143-1144. doi: 10.1001/jamaophthalmol.2021.3192.
- Results publication: PubMed 29887334Wallace DK, Dean TW, Hartnett ME, Kong L, Smith LE, Hubbard GB, McGregor ML, Jordan CO, Mantagos IS, Bell EF, Kraker RT; Pediatric Eye Disease Investigator Group. A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments. Ophthalmology. 2018 Dec;125(12):1961-1966. doi: 10.1016/j.ophtha.2018.05.001. Epub 2018 Jun 7.
- Results publication: PubMed 31697304Crouch ER, Kraker RT, Wallace DK, Holmes JM, Repka MX, Collinge JE, Bremer DL, Gray ME, Smith HA, Steinkuller PG; Writing Committee for Pediatric Eye Disease Investigator Group. Secondary 12-Month Ocular Outcomes of a Phase 1 Dosing Study of Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jan 1;138(1):14-20. doi: 10.1001/jamaophthalmol.2019.4488.
- Results publication: PubMed 32324197Wallace DK, Kraker RT, Freedman SF, Crouch ER, Bhatt AR, Hartnett ME, Yang MB, Rogers DL, Hutchinson AK, VanderVeen DK, Haider KM, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Kong L, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jun 1;138(6):698-701. doi: 10.1001/jamaophthalmol.2020.0334.
- 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 PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Related trials for Retinopathy of Prematurity
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)
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
Indiana University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab in people with Retinopathy of Prematurity, run by Jaeb Center for Health Research at 11 sites in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Treatment of ROP (time frame: 4 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390531, which also lists 5 linked publications.
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 3 Nov 2022.