Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
NCT ID: NCT03054766
Last Updated: 2022-12-28
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2017-02-14
2019-01-28
Brief Summary
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Detailed Description
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The result of the trial will be used to support new therapy in the BRVO in China.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ranibizumab only
Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Sham macular laser
Ranibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Ranibizumab combined macular laser
Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization
Interventions :Ranibizumab injection Interventions :Macular laser photocoagulation
Ranibizumab combined macular laser
subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.
Ranibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Interventions
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Ranibizumab combined macular laser
subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.
Ranibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female Chinese patients ≥ 18 years of age with BRVO
3. Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye
Exclusion Criteria
2. Stroke or myocardial infarction less than 3 months prior to screening visit
3. Renal failure or creatinine levels \> 2.0 mg/dl
4. Uncontrolled hypertension
5. Active ocular infection or intraocular inflammation in any eye
6. Neovascularization of the iris or neovascular glaucoma in any eye
7. History of uveitis or vitreomacular traction in any eye
8. Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
9. Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
10. Active proliferative diabetic retinopathy in study eye
11. Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
12. Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
13. History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
14. History of vitrectomy in study eye
18 Years
90 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Responsible Party
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Yu Xiaobing
M.D
Principal Investigators
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Xiao-bing Yu, M.D
Role: STUDY_CHAIR
Beijing Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Pece A, Isola V, Piermarocchi S, Calori G. Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. Br J Ophthalmol. 2011 Jan;95(1):56-68. doi: 10.1136/bjo.2009.174060. Epub 2010 Jul 3.
Song S, Yu X, Zhang P, Gu X, Dai H. Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial. BMC Ophthalmol. 2020 Jun 19;20(1):241. doi: 10.1186/s12886-020-01498-7.
Other Identifiers
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121-2016001
Identifier Type: -
Identifier Source: org_study_id