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
Overview
- Phase
- Phase 2
- Intervention
- ranibizumab
- Conditions
- Retinal Vein Occlusion
- Sponsor
- University of Pecs
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
- Last Updated
- 15 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Lucentis (ranibizumab)
Intervention: ranibizumab
Laser
Intervention: Argon laser treatment
Outcomes
Primary Outcomes
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
Time Frame: 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 Outcomes
- Efficacy assessed by change in macular thickness(12 months with monthly assessment)