Retinopathy of Prematurity Both EyesPhase 3NCT05033106
Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity
A Phase 3 study testing Bevacizumab, Ranibizumab in people with Retinopathy of Prematurity Both Eyes, run by Zagazig University at 1 site in Egypt.
Trial summary
Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy of Prematurity Both Eyes
- What is being tested?
- Bevacizumab, Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants with a birth weight of ≤ 1500 g or geststional age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Patients with bilateral disease who will receive bilateral injections, are only included. Type 1 ROP according to ETROP study which is defined as, Zone I ROP with plus disease, Zone I, stage 3 ROP without plus disease and Zone II, stage 2 or 3 ROP with plus disease.
Who cannot join
- Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or 5. Eyes with mucopurulent or purulent conjunctivitis. Infants who will not be able to comply to the follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, 002055
Ghada Mahmoud Tawfik Eladawy, Msc, 01006780358, dr_ghadaeladawy@yahoo.com
About this study
Official title: Comparison Between Intravitreal Injection of Ranibizumab and Bevacizumab for Treatment of Type 1 Retinopathy of Prematurity
Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Read the detailed description
Objectives
To compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Study population \& Sample size Infants with Type 1 ROP (affecting both eyes) screened at neonatal intensive care unit (NICU) of Cairo University.
The sample size is calculated to be 36 eyes of 18 infants using open Epi confidence total 95%, power of the study 80% according to the following : the mean SD of axial length of patients with stage 3 ROP using bevacizumab versus ranibizumab (20.3 1.16 versus 19.4 ).
Study Design
This is a prospective, comparative, interventional non inferiority study.
Methods
- Infants with type 1 ROP affecting both eyes will be included.
- Before intravitreal injection, the parents or legal guardian of the infants will be informed about the procedure.
- After written consent is obtained, the pupil will be dilated with 2.5% phenylephrine and 0.5% tropicamide injection.
- The injections will be performed in the operating theatre under general (light inhalational anesthesia) or topical anesthesia with Benoxinate hydrochloride 0.4%.
- Povidone iodine10% swab will be applied on the eyelids and eyelashes. A sterile eyelid speculum will be inserted. Each eye will be meticulously bathed with 5% povidone iodine solution for 3 min before intravitreal injection.
- A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.
- Fundus examination will be conducted with an indirect ophthalmoscope and a 28-D lens. The central retinal artery and the lens will be evaluated in addition to whether a retinal tear is present.
- Postoperative moxifloxacin 0.4% drops will be prescribed 4 times daily for one week.
- Patients will be seen 24 hours after first injection, to monitor for any signs of infection.
- Infants will then be seen weekly for 4 weeks and dilated fundus examination and and digital coloured fundus images by RetCam will be performed to document response of the disease.
- Success criteria to the IVB injection will be defined as, during the follow up period of 60 weeks' postmenstrual age:
- recovery of the plus disease
- regression of any stage of ROP
- progression of peripheral retinal vascularization
- If any progression occurs in the disease course, in terms of: increase in plus disease or progression to higher stage of ROP, immediate second IVB dose 0.625mg will be given to either groups.
- Follow-up will be continued for a minimum of one year corrected age or until we ensure complete peripheral retinal vascularization.
- Conditions
- Retinopathy of Prematurity Both Eyes
- Being tested
- Bevacizumab, Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab, RanibizumabDrug
Also called avastin, leucentis
- A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.
| Study group | Role | What they receive |
|---|---|---|
| Eyes with IVI bevacizumab | Active comparator | 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye Receives: Drug: Bevacizumab, Ranibizumab |
| Eyes with IVI ranibizumab | Active comparator | A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant Receives: Drug: Bevacizumab, Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.
regression of plus disease and the active neovessels
Measured: 60 weeks PMA
Secondary outcomes (1)
• Recurrence of ROP
(recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment)
Measured: 60 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
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.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ghada Mahmoud Tawfik Ibrahim Eladawy, Zagazig University
- Investigators
- Ghada Mahmoud Tawfik Eladawy, Msc, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033106
- Sponsor's protocol ID
- D-9-2020
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: International Publishing
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intravitreal Injection of Ranibizumab and Bevacizumab for Treatment of Type 1 Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT05033106
- Acronym / sponsor ID
- D-9-2020
- Conditions
- Retinopathy of Prematurity Both Eyes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Cairo University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 2 Sep 2021 (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.
Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Detailed description
Objectives
To compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Study population \& Sample size Infants with Type 1 ROP (affecting both eyes) screened at neonatal intensive care unit (NICU) of Cairo University.
The sample size is calculated to be 36 eyes of 18 infants using open Epi confidence total 95%, power of the study 80% according to the following : the mean SD of axial length of patients with stage 3 ROP using bevacizumab versus ranibizumab (20.3 1.16 versus 19.4 ).
Study Design
This is a prospective, comparative, interventional non inferiority study.
Methods
- Infants with type 1 ROP affecting both eyes will be included.
- Before intravitreal injection, the parents or legal guardian of the infants will be informed about the procedure.
- After written consent is obtained, the pupil will be dilated with 2.5% phenylephrine and 0.5% tropicamide injection.
- The injections will be performed in the operating theatre under general (light inhalational anesthesia) or topical anesthesia with Benoxinate hydrochloride 0.4%.
- Povidone iodine10% swab will be applied on the eyelids and eyelashes. A sterile eyelid speculum will be inserted. Each eye will be meticulously bathed with 5% povidone iodine solution for 3 min before intravitreal injection.
- A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.
- Fundus examination will be conducted with an indirect ophthalmoscope and a 28-D lens. The central retinal artery and the lens will be evaluated in addition to whether a retinal tear is present.
- Postoperative moxifloxacin 0.4% drops will be prescribed 4 times daily for one week.
- Patients will be seen 24 hours after first injection, to monitor for any signs of infection.
- Infants will then be seen weekly for 4 weeks and dilated fundus examination and and digital coloured fundus images by RetCam will be performed to document response of the disease.
- Success criteria to the IVB injection will be defined as, during the follow up period of 60 weeks' postmenstrual age:
- recovery of the plus disease
- regression of any stage of ROP
- progression of peripheral retinal vascularization
- If any progression occurs in the disease course, in terms of: increase in plus disease or progression to higher stage of ROP, immediate second IVB dose 0.625mg will be given to either groups.
- Follow-up will be continued for a minimum of one year corrected age or until we ensure complete peripheral retinal vascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with IVI bevacizumab | Active comparator | Drug: Bevacizumab, Ranibizumab0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye |
| Eyes with IVI ranibizumab | Active comparator | Drug: Bevacizumab, RanibizumabA dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infants with a birth weight of ≤ 1500 g or geststional age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Patients with bilateral disease who will receive bilateral injections, are only included. Type 1 ROP according to ETROP study which is defined as, Zone I ROP with plus disease, Zone I, stage 3 ROP without plus disease and Zone II, stage 2 or 3 ROP with plus disease.
Key exclusion criteria (1 listed)
- Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or 5. Eyes with mucopurulent or purulent conjunctivitis. Infants who will not be able to comply to the follow-up schedule.
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, RanibizumabAlso: avastin, leucentis• A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease. | Drug | Eyes with IVI bevacizumab, Eyes with IVI ranibizumab |
Primary outcome
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.
Time frame: 60 weeks PMA
regression of plus disease and the active neovessels
1 secondary outcome
• Recurrence of ROP
Time frame: 60 weeks PMA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Yes. International Publishing
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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.
Ghada Mahmoud Tawfik Eladawy, Msc principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab, Ranibizumab in people with Retinopathy of Prematurity Both Eyes, run by Zagazig University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 2 Sep 2021. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada Mahmoud Tawfik Eladawy, Msc (00201006780358, dr_ghadaeladawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age. (time frame: 60 weeks PMA). 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 2 Sep 2021.