Macular edema secondary to central retinal vein occlusion.
Conditions
Interventions
Trade Name: Eylea
Product Name: Eylea
Product Code: Eylea
Pharmaceutical Form: Solution for injection
Sponsors
Fundación Retinaplus +
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient ? 50 years old - Patient with newly diagnosis macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 6 months with mean central subfield thickness ? 250 ?m on OCT. - An ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye. - BCVA >20/400 in the fellow eye. - Absence of significant cataract that could affect visual results. - Able to return for ALL clinic visits and complete all study-related procedures. - Absence of other ocular diseases that could affect visual acuity. - Willingness to provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Previous anti-VEGF therapy, photodynamic therapy or thermal laser in the study eye. - Recent cataract surgery (<3 months) in the study eye. - Any concurrent ocular disease that could affect the final outcome (diabetic retinopathy, advanced glaucoma, pathologic myopia). - No scar, fibrosis, atrophy or hemorrage involving the center of the fovea - No RPE rip/tear involving the central fovea - Severe proliferative macular ischemia patients and iris rubeosis patients - Participation in any other interventional clinical trial - History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye - Active intraocular inflammation in the study eye - History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. ? Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate changes in visual acuity during the first year after macular edema secondary to central retinal vein occlusion (CRVO) diagnosis, in terms of mean change in EDTRS visual acuity at 12-months (52 weeks) from baseline.;Secondary Objective: - Proportion of patients gaining 15 or more letters as measured by ETDRS at 52-weeks from baseline - Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks. - Mean change in foveal thickness on SD-OCT (spectral domain optical coherence tomography) scans at 24 weeks & 52 weeks. - Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks. - Mean number of intravitreal injections. - Percentage of patients only requiring mandatory doses;Primary end point(s): Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12-months (52 weeks).;Timepoint(s) of evaluation of this end point: Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients gaining 15 or more letters at 12-months measured by ETDRS Scale Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks measured by ETDRS Scale. Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks. Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks. Mean number of intravitreal injections. Percentage of patients only requiring mandatory doses;Timepoint(s) of evaluation of this end point: Specified above. | — |
Countries
Spain
Contacts
Public ContactNoelia Escalona
Trial Form Support
Outcome results
None listed