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Clinical Trials/NCT02381730
NCT02381730
Completed
Not Applicable

Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment

Fondation Ophtalmologique Adolphe de Rothschild3 sites in 1 country37 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Intravitreal aflibercept
Conditions
Polypoidal Choroidal Vasculopathy
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
37
Locations
3
Primary Endpoint
Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Active polypoidal choroidal vasculopathy,
  • Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
  • Age above 45
  • No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
  • Intravitreal injection of aflibercept is indicated by current clinical recommendations

Exclusion Criteria

  • Simultaneous treatment with another anti-VEGM agent
  • Diabetic retinopathy
  • Personal history of vitrectomy or uveitis
  • Personal history laser photocoagulation and/or verteporphin phototherapy
  • Tear in the pigmentary epithelium
  • Chorioretinitis scar
  • Macular atrophy in the pigmentary epithelium
  • Treatment with corticosteroids
  • Eye surgery less than 3 months before inclusion

Arms & Interventions

Aflibercept

Intervention: Intravitreal aflibercept

Outcomes

Primary Outcomes

Evolution of the best corrected visual acuity (BCVA) measured on the EDTRS scale, between pre-injection and 28 weeks after injection

Time Frame: 28 weeks

Study Sites (3)

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