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

University of Pecs40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Vein Occlusion Macular Edema

Interventions

ranibizumabDRUG

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

Argon laser treatmentRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Debrecen Medical and Health Science Center Dept of Ophthalmology

Debrecen, Hungary

RECRUITING

University of Pecs, Medical School, Department of Ophthalmology

Pécs, Hungary

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: 12 months

Secondary Outcomes

Efficacy assessed by change in macular thickness

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.

Time frame: 12 months with monthly assessment

Central Contacts

Zsolt Balla, MD

CONTACT

+3672536141 balla07@freemail.hu

Data from ClinicalTrials.gov

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