Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion (BRAVO)
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|ClinicalTrials.gov Identifier: NCT01123564|
Recruitment Status : Unknown
Verified May 2010 by University of Pecs.
Recruitment status was: Recruiting
First Posted : May 14, 2010
Last Update Posted : May 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion Macular Edema||Drug: ranibizumab Radiation: Argon laser treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2009|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
|Experimental: Lucentis (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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123564
|Contact: Zsolt Balla, MDfirstname.lastname@example.org|
|Debrecen Medical and Health Science Center Dept of Ophthalmology||Recruiting|
|Debrecen, Hungary, H-4012|
|Contact: Attila Vajas, MD email@example.com|
|Principal Investigator: Attila Vajas, MD|
|University of Pecs, Medical School, Department of Ophthalmology||Recruiting|
|Pecs, Hungary, H-7624|
|Contact: Zsolt Balla, MD +3672536141 firstname.lastname@example.org|
|Principal Investigator: Zsolt Balla, MD PhD|
|Principal Investigator:||Zsolt Balla, MD PhD||University of Pecs|