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

University of Pecs

Status and phase

Unknown

Phase 2

Conditions

Macular Edema

Retinal Vein Occlusion

Treatments

Radiation: Argon laser treatment

Drug: ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01123564

CRFB002AHU02T

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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