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Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion (BRAVO)

Primary Purpose

Retinal Vein Occlusion, Macular Edema

Status
Unknown status
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
ranibizumab
Argon laser treatment
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring macular edema secondary to retinal vein occlusion

Eligibility Criteria

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

Inclusion Criteria:

  • Macular edema persisting for more than 3 months period despite conventional medication.
  • Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
  • Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
  • Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
  • Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).

Exclusion Criteria:

  • Diabetes mellitus
  • Additional vitreoretinal diseases
  • History of pars plana vitrectomy
  • Previous macular grid laser treatment
  • Intravitreal triamcinolone acetonid treatment
  • Complicated cataract surgery
  • Advanced glaucomatous damage of optic nerve head
  • Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
  • Age-related macular degeneration
  • Pregnancy and lactation
  • Women in childbearing potential who are not using double safe contraception

Sites / Locations

  • Debrecen Medical and Health Science Center Dept of OphthalmologyRecruiting
  • University of Pecs, Medical School, Department of OphthalmologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lucentis (ranibizumab)

Laser

Arm Description

Outcomes

Primary Outcome Measures

Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly.

Secondary Outcome Measures

Efficacy assessed by change in macular thickness
The efficacy of treatment concerning change of anatomical structure of macular region detected by Optical Coherence Tomography (OCT) - the mean change of macular thickness (micron) at each months of 1 year period.

Full Information

First Posted
May 12, 2010
Last Updated
May 13, 2010
Sponsor
University of Pecs
Collaborators
University of Debrecen
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1. Study Identification

Unique Protocol Identification Number
NCT01123564
Brief Title
Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
Acronym
BRAVO
Official Title
A Randomized, Controlled, Two-center Phase II Study Assessing the Efficacy and Safety of Intravitreal Lucentis Injections in Patients With Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pecs
Collaborators
University of Debrecen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Macular Edema
Keywords
macular edema secondary to retinal vein occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lucentis (ranibizumab)
Arm Type
Experimental
Arm Title
Laser
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis intravitreal injection
Intervention Description
applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
Intervention Type
Radiation
Intervention Name(s)
Argon laser treatment
Other Intervention Name(s)
Laser photocoagulation
Intervention Description
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
Primary Outcome Measure Information:
Title
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
Description
To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy assessed by change in macular thickness
Description
The efficacy of treatment concerning change of anatomical structure of macular region detected by Optical Coherence Tomography (OCT) - the mean change of macular thickness (micron) at each months of 1 year period.
Time Frame
12 months with monthly assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Macular edema persisting for more than 3 months period despite conventional medication. Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG). Patients randomized into ranibizumab-treated group do not receive macular laser treatment. Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis. Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent). Exclusion Criteria: Diabetes mellitus Additional vitreoretinal diseases History of pars plana vitrectomy Previous macular grid laser treatment Intravitreal triamcinolone acetonid treatment Complicated cataract surgery Advanced glaucomatous damage of optic nerve head Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract) Age-related macular degeneration Pregnancy and lactation Women in childbearing potential who are not using double safe contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zsolt Balla, MD
Phone
+3672536141
Email
balla07@freemail.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsolt Balla, MD PhD
Organizational Affiliation
University of Pecs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Debrecen Medical and Health Science Center Dept of Ophthalmology
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attila Vajas, MD
Email
vajasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Attila Vajas, MD
Facility Name
University of Pecs, Medical School, Department of Ophthalmology
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Balla, MD
Phone
+3672536141
Email
balla07@freemail.hu
First Name & Middle Initial & Last Name & Degree
Zsolt Balla, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

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