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Clinical Trials/EUCTR2014-000975-21-ES
EUCTR2014-000975-21-ES
Active, not recruiting
Phase 1

A phase IV study to evaluate the effectiveness of aflibercept in naive patients with macular edema secondary to Central Retinal Vein Occlusion (CRVO) on an individualized Treat and Extend regimen. NEUTON study. - NEUTO

Fundación Retinaplus +0 sitesJune 9, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Macular edema secondary to central retinal vein occlusion.
Sponsor
Fundación Retinaplus +
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 9, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación Retinaplus +

Eligibility 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:

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.

Outcomes

Primary Outcomes

Not specified

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