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

Phase 2

• Conditions: Retinal Vein Occlusion; Macular Edema
• Interventions: Radiation: Argon laser treatment; Drug: ranibizumab

• Registration Number: NCT01123564
• Lead Sponsor: University of Pecs

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Last Update Submitted: 2010-05-13
• Study First Posted: 2010-05-14
• Last Update Posted: 2010-05-14
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Argon laser treatment	-
Lucentis (ranibizumab)	ranibizumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Pecs, Medical School, Department of Ophthalmology; 🇭🇺 Pecs, Hungary

Debrecen Medical and Health Science Center Dept of Ophthalmology; 🇭🇺 Debrecen, Hungary