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

NCT03054766 | Completed DMC

• 1 other identifier: 121-2016001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion; Ranibizumab; Laser Photocoagulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• visual acuity changes

  comparing the changes of visual acuity between the two groups

  one year

Study Arms (2)

Ranibizumab only

EXPERIMENTAL

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

Ranibizumab combined macular laser

EXPERIMENTAL

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; Drug: Ranibizumab

Interventions

Ranibizumab combined macular laser PROCEDURE

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

Ranibizumab combined macular laser

Ranibizumab DRUG

all subjections received 3+PRN ranibizumab injections by BCVA stabilization

Also known as: Lucentis

Ranibizumab combined macular laser; Ranibizumab only

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (2)

• 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.

  PMID: 20601660 BACKGROUND

• 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.

  PMID: 32560639 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xiao-bing Yu, M.D

  Beijing Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 16, 2017
• Study Start: February 14, 2017
• Primary Completion: February 1, 2018
• Study Completion: January 28, 2019
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)