Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
NCT ID: NCT04601701
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
2020-10-17
2021-09-17
Brief Summary
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Detailed Description
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Bevacizumab, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Bevacizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.
Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CRVO: Bevacizumab and intravitreal Dexamethasone.
Participants with CRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
Bevacizumab Ophthalmic and Intravitreal Dexamethasone.
Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
CRVO: Bevacizumab
Participants with CRVO will receive a combination of Bevacizumab only.
Bevacizumab Ophthalmic.
Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
Interventions
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Bevacizumab Ophthalmic and Intravitreal Dexamethasone.
Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
Bevacizumab Ophthalmic.
Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, 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 CRVO
3. BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
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 antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
8. Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
9. Focal or grid laser photocoagulation within 4 months before Baseline 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, M.D., Ph.D.
Role: STUDY_CHAIR
He Eye Specialist Hospital, Shenyang.
Jun Li, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
He Eye Specialist Hospital, Shenyang.
Emmanuel E Pazo, M.D., Ph.D.
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-270620
Identifier Type: -
Identifier Source: org_study_id