Macular EdemaPhase 3NCT04955171
BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema
A Phase 3 study testing BEOVU intravitreal injection in people with Macular Edema, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- BEOVU intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Jan 2021to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic macular edema
Who cannot join
- other causes of macular edema
- other macular diseases
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK R ELHAMAKY, MD
About this study
Official title: Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema
Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management
Read the detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)
- Conditions
- Macular Edema
- Being tested
- BEOVU intravitreal injection
- Keywords
- BEOVU, Eylea, diabetic macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEOVU intravitreal injectionDrug
Also called Brolucizumab-Dbll intravitreal injection
BEOVU intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| BEOVU | Active comparator | Intravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen Receives: Drug: BEOVU intravitreal injection |
| Eylea | Active comparator | Intravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen Receives: Drug: BEOVU intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start12 Jan 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Benha 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
- Investigators
- TAREK ELHAMAKY, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955171
- Sponsor's protocol ID
- Hamaky15
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by direct contact through email
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04955171
- Acronym / sponsor ID
- Hamaky15
- Conditions
- Macular Edema
- Keywords
- BEOVU, Eylea, diabetic macular edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 8 Jul 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.
Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management
Detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEOVU | Active comparator | Drug: BEOVU intravitreal injectionIntravitreal injection of BEOVU 3 loading injections( monthly) then under treat and extent regimen |
| Eylea | Active comparator | Drug: BEOVU intravitreal injectionIntravitreal injection of Eylea 3 loading injections( monthly) then under treat and extent regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic macular edema
Key exclusion criteria (2 listed)
- other causes of macular edema
- other macular diseases
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 |
|---|---|---|
| BEOVU intravitreal injectionAlso: Brolucizumab-Dbll intravitreal injectionBEOVU intravitreal injection | Drug | BEOVU, Eylea |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 12 months
Change in BCVA in LOG MARS(logarithm minimum angle of resolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: Yes. by direct contact through email
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Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
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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.
TAREK ELHAMAKY, MD principal investigator
Benha 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 BEOVU intravitreal injection in people with Macular Edema, run by Benha University at 1 site in United Arab Emirates.
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 2 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 8 Jul 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 United Arab Emirates. 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 TAREK R ELHAMAKY, MD (+9712 443 8999, thamaky@ibnnafees.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) (time frame: 12 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 8 Jul 2021.