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

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intravitreal aflibercept
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Lyon Croix Rousse
  • Fondation Ophtalmologique A. de Rothschild
  • Centre Médical de la Rétine Maison Rouge

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 5, 2015
Last Updated
December 7, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02381730
Brief Title
Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment
Acronym
PCV
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypoidal Choroidal Vasculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravitreal aflibercept
Intervention Description
Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Mauget-Faysse
Organizational Affiliation
Fondation Ophtalmologique A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lyon Croix Rousse
City
Lyon
Country
France
Facility Name
Fondation Ophtalmologique A. de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Centre Médical de la Rétine Maison Rouge
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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