Retinopathy of Prematurity Both EyesPhase 4NCT03148132
VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP
A Phase 4 study testing Bevacizumab Injection and Ranibizumab Ophthalmic in people with Retinopathy of Prematurity Both Eyes and Retinal Disease, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit… Read more about this study
- Who is it for?
- Ages 28 days to 3 months
- Conditions the study is for
- Retinopathy of Prematurity Both Eyes, Retinal Disease, Premature Birth
- What is being tested?
- Bevacizumab Injection and Ranibizumab Ophthalmic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMexico
- Study dates
- 23 May 2017to 30 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 28 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.
Who cannot join
- Patients that do not continue the required evaluations.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78170
About this study
Official title: Comparison of the Vascular Endothelial Growth Factor Serum Concentrations After Intravitreal Use of Bevacizumab or Ranibizumab as a Treatment for Type 1 Retinopathy of Prematurity
The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.
The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus.
The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.
Read the detailed description
It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.
The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis, it's presence is crucial on the growth and development of several tissues around the organism.
Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab.
However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF.
We still don't know the long term effects of the intravitreal application of these drugs on premature babies, but there is the concern.
The objective of this study is to compare the serum VEGF concentrations after intravitreal application of Bevacizumab (0.500mg/0.02mL) versus Ranibizumab (0.25 mg/0.025mL) for the treatment of type 1 ROP.
HYPOTESIS: The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab.
METHODOLOGY: Safety ECCA. Inclusion criteria, premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification.
The investigators will identify the patients that can be included The principal investigator will take a blood sample of 500 microliters and then the patients would receive intravitreal treatment assigned randomly (Bevacizumab 0.5mg/0.02mL or Ranibizumab 0.25mg/0.25 mL).
The principal investigator will take new blood samples a day, 2 weeks and 8 weeks after the application of the intravitreal treatment, these samples will be frozen to further analysis.
The analysis will be performed by ELISA kits.
The investigators are going to describe the results of the ELISA for the blood samples, and then make a comparison between both groups.
- Being tested
- Bevacizumab Injection, Ranibizumab Ophthalmic
- Keywords
- Retinopathy of Prematurity, VEGF, Bevacizumab, Ranibizumab
- Medical subject headings
- Retinal Diseases, Premature Birth, Eye Diseases, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab InjectionDrug
Also called Intravitreal
0.5mg/0.02 mL
Ranibizumab OphthalmicDrug
Also called Intravitreal
0.25mg/0.025 mL
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab injection | Active comparator | Application of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis Receives: Drug: Bevacizumab Injection |
| Ranibizumab Ophthalmic | Experimental | Application of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis Receives: Drug: Ranibizumab Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab
Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start23 May 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity Both EyesStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Patients that fullfil type 1 ROP criteria that will be treated with Bevacizumab Group 2: Patients that fullfil type 1 ROP criteria that will be treated with Ranibizumab
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Principal investigator, Ada Gabriela Hernández Gámez, Universidad Autonoma de San Luis Potosí
- Investigators
- Martha G Rangel, MD, Study director, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148132
- Sponsor's protocol ID
- 31-17
- Status last verified
- Jan 2019
- First submitted
- 8 May 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Vascular Endothelial Growth Factor Serum Concentrations After Intravitreal Use of Bevacizumab or Ranibizumab as a Treatment for Type 1 Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT03148132
- Acronym / sponsor ID
- 31-17
- Keywords
- Retinopathy of Prematurity, VEGF, Bevacizumab, Ranibizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- 23 May 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 10 May 2017 (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.
The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.
The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP-->ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus.
The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.
Detailed description
It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.
The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis, it's presence is crucial on the growth and development of several tissues around the organism.
Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab.
However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF.
We still don't know the long term effects of the intravitreal application of these drugs on premature babies, but there is the concern.
The objective of this study is to compare the serum VEGF concentrations after intravitreal application of Bevacizumab (0.500mg/0.02mL) versus Ranibizumab (0.25 mg/0.025mL) for the treatment of type 1 ROP.
HYPOTESIS: The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab.
METHODOLOGY: Safety ECCA. Inclusion criteria, premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification.
The investigators will identify the patients that can be included The principal investigator will take a blood sample of 500 microliters and then the patients would receive intravitreal treatment assigned randomly (Bevacizumab 0.5mg/0.02mL or Ranibizumab 0.25mg/0.25 mL).
The principal investigator will take new blood samples a day, 2 weeks and 8 weeks after the application of the intravitreal treatment, these samples will be frozen to further analysis.
The analysis will be performed by ELISA kits.
The investigators are going to describe the results of the ELISA for the blood samples, and then make a comparison between both groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Patients that fullfil type 1 ROP criteria that will be treated with Bevacizumab Group 2: Patients that fullfil type 1 ROP criteria that will be treated with Ranibizumab
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab injection | Active comparator | Drug: Bevacizumab InjectionApplication of Intravitreal Bevacizumab (0.50mg/0.02mL), unique dosis |
| Ranibizumab Ophthalmic | Experimental | Drug: Ranibizumab OphthalmicApplication of Intravitreal Ranibizumab (0.25mg/0.025mL), unique dosis |
Who may qualify
- Ages
- 28 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.
Key exclusion criteria (1 listed)
- Patients that do not continue the required evaluations.
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 |
|---|---|---|
| Bevacizumab InjectionAlso: Intravitreal0.5mg/0.02 mL | Drug | Bevacizumab injection |
| Ranibizumab OphthalmicAlso: Intravitreal0.25mg/0.025 mL | Drug | Ranibizumab Ophthalmic |
Primary outcome
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab
Time frame: 6 months
Evaluate the Serum VEGF concentration with the ELISA assay after intravitreal application of Bevacizumab or ranibizumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Martha G Rangel, MD study director
Hospital Central "Dr. Ignacio Morones Prieto"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab Injection and Ranibizumab Ophthalmic in people with Retinopathy of Prematurity Both Eyes and Retinal Disease, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 1 inclusion and 1 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the serum VEGF concentrations after intravitreal application of Bevacizumab vs Ranibizumab (time frame: 6 months). 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 9 Jan 2019.