Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
NCT ID: NCT04601688
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-10-31
2021-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BRVO: Bevacizumab and intravitreal Dexamethasone
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
Bevacizumab Ophthalmic and Intravitreal Dexamethasone
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.
BRVO: Bevacizumab
Participants with BRVO will receive Bevacizumab only.
Bevacizumab Ophthalmic
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Interventions
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Bevacizumab Ophthalmic and Intravitreal Dexamethasone
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 Ophthalmic
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of visual impairment exclusively due to ME secondary to BRVO
3. BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
4. Central foveal thickness (CFT) ≥ 300 µm
5. Naive Eyes
Exclusion Criteria
2. Stroke or myocardial infarction less than 3 months before Screening
3. Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline.
4. Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
5. Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
6. Neovascularization of the iris or neovascular glaucoma in the study eye
7. Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
8. Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye
9. Focal or grid laser photocoagulation in the study eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
11. Any use of intraocular corticosteroid implants (eg, dexamethasone \[Ozurdex®\], fluocinolone acetonide \[Iluvien®\]) in the study eye
18 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei He
Role: STUDY_CHAIR
He Eye Specialist Hospital, Shenyang.
Jun Li
Role: PRINCIPAL_INVESTIGATOR
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo
Role: STUDY_DIRECTOR
He Eye Specialist Hospital, Shenyang.
Locations
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He Eye Specialist Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ME-260620
Identifier Type: -
Identifier Source: org_study_id