Retinopathy of PrematurityPhase 3NCT05712642
A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
A Phase 3 study testing Intravitreal Bevacizumab in people with Retinopathy of Prematurity, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding : Serum Systemic VEGF levels. Retinal Vascularization. Read more about this study
- Who is it for?
- Ages 28 to 40 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Intravitreal Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 28 Jan 2021
- 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 28 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with 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
- Zone II, stage 2 or 3 ROP with plus disease
Who cannot join
- Eyes with previous intravitreal injection
- Eyes with previous laser therapy
- Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :
Serum Systemic VEGF levels. Retinal Vascularization.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Intravitreal 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.
Intravitreal BevacizumabDrug
Also called Avastin
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Group A recieved 0.3125mg intravitreal bevacizumab in both eyes | Experimental | 9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . Receives: Drug: Intravitreal Bevacizumab |
| Group B received 0.625mg intravitreal bevacizumab in both eyes | Active comparator | 10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . Receives: Drug: Intravitreal Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
serum systemic VEGF measured using human VEGF ELISA kit
Measured: at day 0 (baseline ) , 1 week and 4 weeks post-injection
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.
Measured: "up to 60 weeks postmenstrual age"
Secondary outcomes (1)
Occurrence of any adverse events from intravitreal-injection
endophthalmitis , retinal detachment , cataract , vitreous hemorrhage
Measured: Within 4 weeks from intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2020
- Primary completion30 Dec 2020
- Study completion28 Jan 2021
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.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nooran Mohammed Abdelhameed Abdelkader, Cairo University
- Investigators
- Nooran Abdelkader, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712642
- Sponsor's protocol ID
- MD-108-2019
- Status last verified
- Feb 2023
- First submitted
- 17 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
- ClinicalTrials.gov ID
- NCT05712642
- Acronym / sponsor ID
- MD-108-2019
- Conditions
- Retinopathy of Prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 3 Feb 2023 (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 aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :
Serum Systemic VEGF levels. Retinal Vascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A recieved 0.3125mg intravitreal bevacizumab in both eyes | Experimental | Drug: Intravitreal Bevacizumab9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . |
| Group B received 0.625mg intravitreal bevacizumab in both eyes | Active comparator | Drug: Intravitreal Bevacizumab10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . |
Who may qualify
- Ages
- 28 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Zone I ROP with plus disease
- Zone I, stage 3 ROP without plus disease
- Zone II, stage 2 or 3 ROP with plus disease
Key exclusion criteria (3 listed)
- Eyes with previous intravitreal injection
- Eyes with previous laser therapy
- Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
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 |
|---|---|---|
| Intravitreal BevacizumabAlso: AvastinSerum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab | Drug | Group A recieved 0.3125mg intravitreal bevacizumab in both eyes, Group B received 0.625mg intravitreal bevacizumab in both eyes |
Primary outcome
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.
Time frame: at day 0 (baseline ) , 1 week and 4 weeks post-injection
serum systemic VEGF measured using human VEGF ELISA kit
The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.
Time frame: "up to 60 weeks postmenstrual age"
Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.
1 secondary outcome
Occurrence of any adverse events from intravitreal-injection
Time frame: Within 4 weeks from intravitreal injection
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 3 Feb 2023.
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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.
Nooran Abdelkader, MD principal investigator
Cairo 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 Intravitreal Bevacizumab in people with Retinopathy of Prematurity, run by Cairo 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 4 inclusion and 3 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 Feb 2023. 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?
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?
Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups. (time frame: at day 0 (baseline ) , 1 week and 4 weeks post-injection). The study lists 2 primary outcomes in all. 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 3 Feb 2023.