Back to resultsBranch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
Primary Purpose
Branch Retinal Vein Occlusion
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bevacizumab Ophthalmic and Intravitreal Dexamethasone
Bevacizumab Ophthalmic
Sponsored by
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- He Eye Specialist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BRVO: Bevacizumab and intravitreal Dexamethasone
BRVO: Bevacizumab
Arm Description
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
Participants with BRVO will receive Bevacizumab only.
Outcomes
Primary Outcome Measures
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.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Secondary Outcome Measures
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.
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.
Number of Bevacizumab. Treatments
Number of injections provided to the patients during the 6 month period.
Mean change in NEI VFQ25
Scores from NEI VFQ25 questionnaire is assessed and compared.
Mean change in EQ-5D 5L
Scores from EQ-5D 5L questionnaire is assessed and compared.
Mean change in VisQoL scores
Scores from VisQoL questionnaire is assessed and compared.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared.
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.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04601688
Brief Title
Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
Official Title
Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2020 (Anticipated)
Primary Completion Date
March 2, 2021 (Anticipated)
Study Completion Date
September 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
He Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BRVO: Bevacizumab and intravitreal Dexamethasone
Arm Type
Experimental
Arm Description
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
Arm Title
BRVO: Bevacizumab
Arm Type
Active Comparator
Arm Description
Participants with BRVO will receive Bevacizumab only.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Ophthalmic and Intravitreal Dexamethasone
Other Intervention Name(s)
Avastin®, Ozurdex®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab Ophthalmic
Other Intervention Name(s)
Avastin®
Intervention Description
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Primary Outcome Measure Information:
Title
Mean change in monocular BCVA in the treatment eye
Description
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Time Frame
Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in binocular BCVA
Description
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Time Frame
Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary Outcome Measure Information:
Title
Mean change in central subfield retinal thickness
Description
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT) is assessed and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Change in Humphrey 10-2 visual field in the treatment eye
Description
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Number of Bevacizumab. Treatments
Description
Number of injections provided to the patients during the 6 month period.
Time Frame
Day 1 through Month 6
Title
Mean change in NEI VFQ25
Description
Scores from NEI VFQ25 questionnaire is assessed and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in EQ-5D 5L
Description
Scores from EQ-5D 5L questionnaire is assessed and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in VisQoL scores
Description
Scores from VisQoL questionnaire is assessed and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in wavefront aberrations
Description
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in ocular surface and tear-film
Description
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Mean change in vessel density
Description
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
Side effects
Description
Side effects are measured by a review of the participant's medical and ophthalmic history.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Title
People meeting driving standards
Description
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared.
Time Frame
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, M.D., Ph.D.
Phone
0086-15104083505
Email
robin_lijun@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel E Pazo
Phone
0086-18612782131
Email
ericpazo@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei He
Organizational Affiliation
He Eye Specialist Hospital, Shenyang.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jun Li
Organizational Affiliation
He Eye Specialist Hospital, Shenyang.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel E Pazo
Organizational Affiliation
He Eye Specialist Hospital, Shenyang.
Official's Role
Study Director
Facility Information:
Facility Name
He Eye Specialist Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D., Ph.D.
Phone
0086-15104083505
Email
robin_lijun@sina.com
First Name & Middle Initial & Last Name & Degree
Emmanuel Eric Pazo, M.D., Ph.D.
Phone
0086-18612782131
Email
ericpazo@outlook.com
First Name & Middle Initial & Last Name & Degree
Qiqi Zhong, M.D.
First Name & Middle Initial & Last Name & Degree
Lanting Yang, M.D.
12. IPD Sharing Statement
Learn more about this trial
Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
We'll reach out to this number within 24 hrs