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

December 25, 2022 updated by: Yu Xiaobing, Beijing Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity changes
Time Frame: one year
comparing the changes of visual acuity between the two groups
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 25, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121-2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

share the results of the study,and one can send message to yuxiaobing@sina.come for information

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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