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

Primary Purpose

Branch Retinal Vein Occlusion, Ranibizumab, Laser Photocoagulation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ranibizumab combined macular laser

Ranibizumab

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Male or female Chinese patients ≥ 18 years of age with BRVO
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:

Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
Stroke or myocardial infarction less than 3 months prior to screening visit
Renal failure or creatinine levels > 2.0 mg/dl
Uncontrolled hypertension
Active ocular infection or intraocular inflammation in any eye
Neovascularization of the iris or neovascular glaucoma in any eye
History of uveitis or vitreomacular traction in any eye
Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
Active proliferative diabetic retinopathy in study eye
Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
History of vitrectomy in study eye
Other protocol defined inclusion /exclusion criteria may apply

Sites / Locations

Beijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ranibizumab only

Ranibizumab combined macular laser

Arm Description

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

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

Outcomes

Primary Outcome Measures

visual acuity changes

comparing the changes of visual acuity between the two groups

Secondary Outcome Measures

Full Information

NCT ID

NCT03054766

First Posted

February 5, 2017

Last Updated

December 25, 2022

Sponsor

Beijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03054766

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

February 14, 2017 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Branch Retinal Vein Occlusion, Ranibizumab, Laser Photocoagulation

Keywords

Laser Photocoagulation, Ranibizumab, Branch Retinal Vein Occlusion, Vascular Endothecial Growth Factor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab only

Arm Type

Experimental

Arm Description

Arm Title

Ranibizumab combined macular laser

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ranibizumab combined macular laser

Intervention Description

subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

all subjections received 3+PRN ranibizumab injections by BCVA stabilization

Primary Outcome Measure Information:

Title

visual acuity changes

Description

comparing the changes of visual acuity between the two groups

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Male or female Chinese patients ≥ 18 years of age with BRVO 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: Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception Stroke or myocardial infarction less than 3 months prior to screening visit Renal failure or creatinine levels > 2.0 mg/dl Uncontrolled hypertension Active ocular infection or intraocular inflammation in any eye Neovascularization of the iris or neovascular glaucoma in any eye History of uveitis or vitreomacular traction in any eye Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye Active proliferative diabetic retinopathy in study eye Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening History of vitrectomy in study eye Other protocol defined inclusion /exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao-bing Yu, M.D

Organizational Affiliation

Beijing Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

20601660

Citation

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.

Results Reference

background

PubMed Identifier

32560639

Citation

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.

Results Reference

derived

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

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