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Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO

Sponsor
Beijing Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03054766
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
28.2
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.

The result of the trial will be used to support new therapy in the BRVO in China.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion
Actual Study Start Date :
Sep 21, 2016
Actual Primary Completion Date :
Sep 21, 2017
Actual Study Completion Date :
Jan 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Ranibizumab
all subjections received 3+PRN ranibizumab injections by BCVA stabilization
Other Names:
  • Lucentis

    		•
    Experimental: 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

    Procedure: 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.

    Drug: Ranibizumab
    all subjections received 3+PRN ranibizumab injections by BCVA stabilization
    Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. visual acuity changes [one year]

      comparing the changes of visual acuity between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Written informed consent

    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:

    1. Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception

    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

    15. Other protocol defined inclusion /exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Beijing Hospital

    Investigators

    • Study Chair: Xiao-bing Yu, M.D, Beijing Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yu Xiaobing, M.D, Beijing Hospital
    ClinicalTrials.gov Identifier:
    NCT03054766
    Other Study ID Numbers:
    • 121-2016001
    First Posted:
    Feb 16, 2017
    Last Update Posted:
    Jan 22, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Yu Xiaobing, M.D, Beijing Hospital
    Laser Photocoagulation
    Ranibizumab
    Branch Retinal Vein Occlusion
    Vascular Endothecial Growth Factor
    Additional relevant MeSH terms:
    Retinal Vein Occlusion
    Ranibizumab

    Study Results

    No Results Posted as of Jan 22, 2020