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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Pecs.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Debrecen
Information provided by:
University of Pecs
ClinicalTrials.gov Identifier:
NCT01123564
First received: May 12, 2010
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Retinal Vein Occlusion
Macular Edema
 Drug: ranibizumab
Radiation: Argon laser treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months with monthly assessment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lucentis intravitreal injection
Active Comparator: Laser Radiation: Argon laser treatment
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
Other Name: Laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123564

Contacts
Contact: Zsolt Balla, MD +3672536141 balla07@freemail.hu

Locations
Hungary
Debrecen Medical and Health Science Center Dept of Ophthalmology Recruiting
Debrecen, Hungary, H-4012
Contact: Attila Vajas, MD         vajasa@gmail.com    
Principal Investigator: Attila Vajas, MD            
University of Pecs, Medical School, Department of Ophthalmology Recruiting
Pecs, Hungary, H-7624
Contact: Zsolt Balla, MD     +3672536141     balla07@freemail.hu    
Principal Investigator: Zsolt Balla, MD PhD            
Sponsors and Collaborators
University of Pecs
University of Debrecen
Investigators
Principal Investigator: Zsolt Balla, MD PhD University of Pecs
  More Information

No publications provided

Responsible Party: Zsolt Balla/assistant lecturer, University of Pecs, Medical Scool, Dept of Ophthalmology
ClinicalTrials.gov Identifier: NCT01123564     History of Changes
Other Study ID Numbers: CRFB002AHU02T
Study First Received: May 12, 2010
Last Updated: May 13, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by University of Pecs:
macular edema secondary to retinal vein occlusion

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013