Efficacy of Aflibercept (Eylea®) on Choroidal Neovascular... | NCT02320474

Studies
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

NCT02320474

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Mar 8, 2019Actual

Enrollment

26Actual

Phase

Phase 4

Conditions

Type 3 Choroidal Neovascularization

Interventions

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

Mar 2019

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

Nov 25, 2014Actual

Primary Completion Date

Nov 2018Actual

Completion Date

Nov 2018Actual

First Submitted Date

Dec 10, 2014

First Submission Date that Met QC Criteria

Dec 15, 2014

First Posted Date

Dec 19, 2014Estimated

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

Mar 7, 2019

Last Update Posted Date

Mar 8, 2019Actual

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

This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
Aflibercept	Experimental		Drug: Aflibercept

Name	Type	Description	Arm Group Labels	Other Names
Aflibercept	Drug		Aflibercept

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in Best Corrected Visual Acuity (BCVA)	Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters	52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females aged more than 50 years
Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality

Exclusion Criteria:

Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
Any previous history of intravitreal injections in the study eye for exudative AMD
Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
Any history of vitrectomy
Media opacities preventing accurate imaging of the retina (cataract)
Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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
Nicolas LEVEZIEL, MD, PhD	CHU Poitiers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poitiers University Hospital		Poitiers		86000	France
Polyclinic of POITIERS