NCT01189526

Brief Summary

This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion. Characteristics of this study is as below

  1. 1.Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
  2. 2.After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 26, 2010

Status Verified

August 1, 2010

Enrollment Period

1.6 years

First QC Date

August 25, 2010

Last Update Submit

August 25, 2010

Conditions

Branch Retinal Vein Occlusion

Keywords

Branch retinal vein occlusionmacular edemaintravitreal injectionranibizumab

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity (ETDRS letters)

    48 weeks

Secondary Outcomes (1)

  • Retinal Thickening

    48 weeks

Study Arms (2)

IVRI

EXPERIMENTAL

IVRI : intravitreal ranibizumab (0.5mg) injection

Drug: Ranibizumab

Laser

ACTIVE COMPARATOR

Laser : macular laser photocoagulation

Procedure: macular laser photocoagulation

Interventions

RanibizumabDRUG

Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.

IVRI
macular laser photocoagulationPROCEDURE

Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

Laser

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptom duration \< 6 Months, \> 4 weeks
  • Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
  • OCT - center involved retinal thickening : \> 250 micrometers
  • clear media
  • well controlled hypertension (\<140/90mmHg) and diabetes (6.5\<HbA1c\<9.5)
  • willing to return for all scheduled visits

You may not qualify if:

  • uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
  • any malignancy
  • previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
  • vitreomacular traction or epiretinal membrane
  • intraocular surgery in the study eye within 6 months
  • uncontrolled glaucoma ( \> 30mmHg with anti-glaucoma medications)
  • optic neuropathy, amblyopia
  • A condition that in the opinion of the investigator would preclude a patient's participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

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

  • Se Woong Kang, M.D.

    Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Jae Pil Shin, M.D.

    Department of Ophthalmology, Kyungpook National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Ee Chung, M.D.

CONTACT

songee129@hanmail.net

Yun Taek Kim, M.D.

CONTACT

jjongofhim@naver.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2011

Last Updated

August 26, 2010

Record last verified: 2010-08

Locations

KR(1)