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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054766
Recruitment Status : Terminated
First Posted : February 16, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Yu Xiaobing, Beijing Hospital

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
Branch Retinal Vein Occlusion Ranibizumab Laser Photocoagulation Procedure: Ranibizumab combined macular laser Drug: Ranibizumab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 21, 2016
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : January 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: 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 Name: Lucentis




Primary Outcome Measures :
  1. visual acuity changes [ Time Frame: one year ]
    comparing the changes of visual acuity between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054766


Locations
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China, Beijing
Beijing Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Hospital
Investigators
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Study Chair: Xiao-bing Yu, M.D Beijing Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yu Xiaobing, M.D, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03054766    
Other Study ID Numbers: 121-2016001
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: share the results of the study,and one can send message to yuxiaobing@sina.come for information

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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, Beijing Hospital:
Laser Photocoagulation
Ranibizumab
Branch Retinal Vein Occlusion
Vascular Endothecial Growth Factor
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents