CClinicalTrials.gg
Sign In
CompletedNCT03054766Updated Dec 28, 2022

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

An interventional study of Ranibizumab combined macular laser and Ranibizumab in Branch Retinal Vein Occlusion, Ranibizumab and Laser Photocoagulation, sponsored by Beijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Beijing Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Branch Retinal Vein Occlusion
  • Ranibizumab
  • Laser Photocoagulation

Keywords

  • Laser Photocoagulation
  • Ranibizumab
  • Branch Retinal Vein Occlusion
  • Vascular Endothecial Growth Factor
03

In context

Retinal Vein Occlusion

282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.

This study's enrollment of 80 is above the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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 · Drug: Ranibizumab

Interventions

  • ProcedureRanibizumab 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.

  • DrugRanibizumab

    all subjections received 3+PRN ranibizumab injections by BCVA stabilization

    Also known as: Lucentis

06

What researchers measure

Primary outcomes

  1. visual acuity changes

    comparing the changes of visual acuity between the two groups

    Time frame: one year

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing 100730, China
08

References and documents

Publications

  • 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. PubMed 20601660 ↗
  • 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. PubMed 32560639 ↗

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03054766
Lead sponsor
Beijing Hospital
Responsible party
Yu Xiaobing (M.D, Beijing Hospital) — Principal investigator
First posted
Feb 16, 2017
Start date
Feb 14, 2017
Primary completion
Feb 1, 2018
Completion
Jan 28, 2019
Last update
Dec 28, 2022

Study contacts

Xiao-bing Yu, M.D
study chair · Beijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Retinal Vein Occlusion→

Other studies from this sponsor

Beijing Hospital

Start the discussion