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

May 13, 2010 updated by: University of Pecs

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Debrecen, Hungary, H-4012
        • Recruiting
        • Debrecen Medical and Health Science Center Dept of Ophthalmology
        • Contact:
        • Principal Investigator:
          • Attila Vajas, MD
      • Pecs, Hungary, H-7624
        • Recruiting
        • University of Pecs, Medical School, Department of Ophthalmology
        • Contact:
        • Principal Investigator:
          • Zsolt Balla, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laser
Radiation: Argon laser treatment
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
Other Names:
  • Laser photocoagulation
Experimental: Lucentis (ranibizumab)
Drug: ranibizumab
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
Other Names:
  • Lucentis intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy assessed by change in macular thickness
Time Frame: 12 months with monthly assessment
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.
12 months with monthly assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Collaborators

University of Debrecen

Investigators

  • Principal Investigator: Zsolt Balla, MD PhD, University of Pecs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002AHU02T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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