Assessment of Visual Acuity in Patients With Polypoidal C... | NCT02381730

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

NCT02381730

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Dec 8, 2017Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Intravitreal aflibercept

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Mar 5, 2015

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2017

Last Update Posted Date

Dec 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aflibercept	Experimental		Drug: Intravitreal aflibercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal aflibercept	Drug	Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)	Aflibercept

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martine Mauget-Faysse	Fondation Ophtalmologique A. de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Lyon Croix Rousse		Lyon			France
Fondation Ophtalmologique A. de Rothschild

Condition Browse Module

MeSH Terms

ID	Term
D000092342	Polypoidal Choroidal Vasculopathy

Ancestor Terms

ID	Term
D020256	Choroidal Neovascularization
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided