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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
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* Drug: ranibizumab
* Radiation: Argon laser treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis (ranibizumab)<br> | Drug: ranibizumab<br>* 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<br>* Other names: Lucentis intravitreal injection;|
| Active Comparator: Laser<br> | Radiation: Argon laser treatment<br>* Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.<br>* Other names: Laser photocoagulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months with monthly assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema secondary to retinal vein occlusion