Branch Retinal Vein OcclusionNCT04601688
Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
A study testing Bevacizumab Ophthalmic and Intravitreal Dexamethasone and Bevacizumab Ophthalmic in people with Branch Retinal Vein Occlusion, run by He Eye Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Bevacizumab Ophthalmic and Intravitreal Dexamethasone and Bevacizumab Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to 17 Sep 2021
- Phase
- Interventional
- 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
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
- Central foveal thickness (CFT) ≥ 300 µm
- Naive Eyes
Who cannot join
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- Neovascularization of the iris or neovascular glaucoma in the study eye
Show all 11Show fewer
- Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye
- Focal or grid laser photocoagulation in the study eye
- Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
- Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
Trial locations and contacts
1 site in 1 country.
China1 site
He Eye Specialist Hospital
Shenyang, Liaoning, 110001
Jun Li, M.D., Ph.D., 0086-15104083505, robin_lijun@sina.com
Emmanuel Eric Pazo, M.D., Ph.D., 0086-18612782131, ericpazo@outlook.com
About this study
Official title: Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.
Read the detailed description
The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Bevacizumab Ophthalmic and Intravitreal Dexamethasone, Bevacizumab Ophthalmic
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Ophthalmic and Intravitreal DexamethasoneDrug
Also called Avastin®, Ozurdex®
Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Bevacizumab OphthalmicDrug
Also called Avastin®
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
| Study group | Role | What they receive |
|---|---|---|
| BRVO: Bevacizumab and intravitreal Dexamethasone | Experimental | Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. Receives: Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone |
| BRVO: Bevacizumab | Active comparator | Participants with BRVO will receive Bevacizumab only. Receives: Drug: Bevacizumab Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in monocular BCVA in the treatment eye
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Measured: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary outcomes (11)
Mean change in central subfield retinal thickness
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT) is assessed and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Number of Bevacizumab. Treatments
Number of injections provided to the patients during the 6 month period.
Measured: Day 1 through Month 6
Mean change in NEI VFQ25
Scores from NEI VFQ25 questionnaire is assessed and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Scores from EQ-5D 5L questionnaire is assessed and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire is assessed and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared.
Measured: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start31 Oct 2020 (estimated)
- Primary completion2 Mar 2021 (estimated)
- Study completion17 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei He, Study chair, He Eye Specialist Hospital, Shenyang.Jun Li, Principal investigator, He Eye Specialist Hospital, Shenyang.Emmanuel E Pazo, Study director, He Eye Specialist Hospital, Shenyang.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601688
- Sponsor's protocol ID
- ME-260620
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
- ClinicalTrials.gov ID
- NCT04601688
- Acronym / sponsor ID
- ME-260620
- Conditions
- Branch Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 17 Sep 2021 (estimated)
- First posted
- 26 Oct 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.
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.
Detailed description
The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRVO: Bevacizumab and intravitreal Dexamethasone | Experimental | Drug: Bevacizumab Ophthalmic and Intravitreal DexamethasoneParticipants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. |
| BRVO: Bevacizumab | Active comparator | Drug: Bevacizumab OphthalmicParticipants with BRVO will receive Bevacizumab only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
- Central foveal thickness (CFT) ≥ 300 µm
- Naive Eyes
Key exclusion criteria (11 listed)
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
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 Ophthalmic and Intravitreal DexamethasoneAlso: Avastin®, Ozurdex®Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected. | Drug | BRVO: Bevacizumab and intravitreal Dexamethasone |
| Bevacizumab OphthalmicAlso: Avastin®Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected. | Drug | BRVO: Bevacizumab |
Primary outcome
Mean change in monocular BCVA in the treatment eye
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Mean change in binocular BCVA
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
11 secondary outcomes
Mean change in central subfield retinal thickness
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Number of Bevacizumab. Treatments
Time frame: Day 1 through Month 6
Mean change in NEI VFQ25
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Side effects
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
People meeting driving standards
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
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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.
Wei He study chair
He Eye Specialist Hospital, Shenyang.
Jun Li principal investigator
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo study director
He Eye Specialist Hospital, Shenyang.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab Ophthalmic and Intravitreal Dexamethasone and Bevacizumab Ophthalmic in people with Branch Retinal Vein Occlusion, run by He Eye Hospital at 1 site in China.
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 5 inclusion and 11 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 26 Oct 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 China. 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.
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 Jun Li, M.D., Ph.D. (0086-15104083505, robin_lijun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in monocular BCVA in the treatment eye (time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.). 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 26 Oct 2020.