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

Sponsor

University of Pecs (Other)

Overall Status

Unknown status

CT.gov ID

NCT01123564

Collaborator

University of Debrecen (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity) [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.

Secondary Outcome Measures

Efficacy assessed by change in macular thickness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Debrecen Medical and Health Science Center Dept of Ophthalmology	Debrecen		Hungary	H-4012
2	University of Pecs, Medical School, Department of Ophthalmology	Pecs		Hungary	H-7624