Study to evaluate the effectiveness of aflibercept in patients with macular edema secondary to central retinal vein occlusion.

Phase 1

Conditions: Macular edema secondary to central retinal vein occlusion.
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2014-000975-21-ES

Lead Sponsor: Fundación Retinaplus +

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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