Dystrophy, RetinalPhase 4NCT04690062
BEOVU in the Treatment of Dystrophy-related Macular Neovascular Degeneration
A Phase 4 study testing Brolucizumab-Dbll in people with Dystrophy, Retinal, run by Benha University at 1 site in United Arab Emirates.
Trial summary
Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dystrophy, Retinal
- What is being tested?
- Brolucizumab-Dbll
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 25 Oct 2020to 30 Dec 2022
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Dystrophy-Related macular neovascularization degeneration
Who cannot join
- age related macular degeneration , other causes of macular neovascularization degeneration
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: Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration
Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.
Read the detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done.
Procedure included intravitreal injection of Brolucizumab (BEOVU®, Genen-tech, South Francisco, CA)
- Conditions
- Dystrophy, Retinal
- Being tested
- Brolucizumab-Dbll
- Keywords
- macular degeneration, BEOVU, RETINAL DYSTROPHY
- Medical subject headings
- Retinal Dystrophies, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brolucizumab-DbllDrug
Also called BEOVU
intravitreal injection of Brolucizumab (BEOVU)
| Study group | Role | What they receive |
|---|---|---|
| BEOVU | Experimental | Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months Receives: Drug: Brolucizumab-Dbll |
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
Secondary outcomes (1)
optical coherence tomography (OCT) foveal thickness
change in foveal thickness measured in micrometer
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 posted30 Dec 2020
- Study start25 Oct 2020
- Primary completion25 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystrophy, RetinalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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 faculty of medicine , INMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690062
- Sponsor's protocol ID
- Hamaky7
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 30 Dec 2020
- 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 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brolucizumab-dbll (BEOVU®) Intravitreal Injection in the Treatment of Dystrophy-related Macular Neovascular Degeneration
- ClinicalTrials.gov ID
- NCT04690062
- Acronym / sponsor ID
- Hamaky7
- Conditions
- Dystrophy, Retinal
- Keywords
- macular degeneration, BEOVU, RETINAL DYSTROPHY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 25 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Dec 2020 (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.
Dystrophy-Related macular neovascularization degeneration occur is a vision threatening condition.The investigators evaluate the efficacy of BEOVU intravitreal treatment.
Detailed description
Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done.
Procedure included intravitreal injection of Brolucizumab (BEOVU®, Genen-tech, South Francisco, CA)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEOVU | Experimental | Drug: Brolucizumab-DbllIntravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Dystrophy-Related macular neovascularization degeneration
Key exclusion criteria (1 listed)
- age related macular degeneration , other causes of macular neovascularization degeneration
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 |
|---|---|---|
| Brolucizumab-DbllAlso: BEOVUintravitreal injection of Brolucizumab (BEOVU) | Drug | BEOVU |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 12 months
Change in BCVA in LOG MARS(logarithm minimum angle of resolution)
1 secondary outcome
optical coherence tomography (OCT) foveal thickness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: Yes. by direct contact through email
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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 faculty of medicine , INMC
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 Brolucizumab-Dbll in people with Dystrophy, Retinal, 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 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 30 Dec 2020. 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 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?
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 (+97126324200, 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 30 Dec 2020.