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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01123564

Acronym

BRAVO

Enrollment

Registered

2010-05-14

Start date

2009-08-31

Completion date

2011-09-30

Last updated

2010-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Retinal Vein Occlusion

Keywords

macular edema secondary to retinal vein occlusion

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

Interventions

DRUGranibizumab

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

RADIATIONArgon laser treatment

Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Hungary

Contacts

Primary ContactZsolt Balla, MD

balla07@freemail.hu+3672536141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026