NCT01795209

Brief Summary

The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

4.9 years

First QC Date

February 18, 2013

Last Update Submit

September 18, 2019

Conditions

Branch Retinal Vein OcclusionMacular Edema

Keywords

Branch retinal vein occlusionMacular edemaRanibizumab

Outcome Measures

Primary Outcomes (1)

  • Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity

    1 year

Secondary Outcomes (12)

  • Mean change from baseline ETDRS letter score over time

    6 months and 1 year

  • Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA

    6 months and 1 year

  • Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA

    6 months and 1 year

  • Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA

    6 months and 1 year

  • Proportion of patients with who at least maintain baseline BCVA

    6 months and 1 year

  • +7 more secondary outcomes

Study Arms (2)

Ranibizumab group

EXPERIMENTAL

Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.

Drug: RanibizumabProcedure: Rescue laser

Standard of care group

SHAM COMPARATOR

Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.

Device: Sham injectionProcedure: Rescue laser

Interventions

RanibizumabDRUG

Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Also known as: Lucentis(ranibizumab), 3mg/0.3ml
Ranibizumab group
Sham injectionDEVICE

Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Standard of care group
Rescue laserPROCEDURE

In the Lucentis group: performed if BCVA \< 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA \< 20/40 or CFT ≥ 350um from Month 3

Ranibizumab groupStandard of care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
  • ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
  • CFT \>= 300 um (mean of measurements obtained at screening and Day 0)
  • Signed consent informed
  • male or female, age ≥18 years old

You may not qualify if:

  • Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
  • BCVA improvement \>10 letters between screening and Day 0
  • History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
  • Laser treatment within 3 months before baseline
  • Intraocular corticosteroid use within 3 months before baseline
  • Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
  • Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
  • Stroke or myocardial infarction ≤3 months before baseline
  • Pregnancy or plan to have baby in female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.

    PMID: 20398941BACKGROUND

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Kyu Hyung Park, M.D.

    Seoul National Univeristy Bundang Hospital

    PRINCIPAL INVESTIGATOR

  • Se Woong Kang, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

KR(2)