NCT02320474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

3.9 years

First QC Date

December 10, 2014

Last Update Submit

March 7, 2019

Conditions

Type 3 Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Aflibercept

EXPERIMENTAL
Drug: Aflibercept

Interventions

AfliberceptDRUG
Aflibercept

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Poitiers University Hospital

Poitiers, 86000, France

Location

Polyclinic of POITIERS

Poitiers, 86000, France

Location

MeSH Terms

Interventions

aflibercept

Study Officials

  • Nicolas LEVEZIEL, MD, PhD

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 19, 2014

Study Start

November 25, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

FR(2)