NCT03803631

Brief Summary

The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

September 11, 2018

Last Update Submit

August 26, 2025

Conditions

AMDExudative Macular Degeneration

Outcome Measures

Primary Outcomes (10)

  • presence of flow on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of collaterals on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of peripheral arcade on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of arteriolization on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of vascular loops on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of dark halo on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of feeder vessel on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • presence of flow void on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • measure of neovascular area on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

  • measure of neovascular density on OCTA

    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

    at month 13

Secondary Outcomes (168)

  • presence of flow on OCTA

    baseline

  • presence of flow on OCTA

    at month 1

  • presence of flow on OCTA

    at month 2

  • presence of flow on OCTA

    at month 3

  • presence of flow on OCTA

    at month 4

  • +163 more secondary outcomes

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with wet-AMD (NVC type 1 or 2) diagnosed maximum one week before inclusion and for whom Aflibercept in intra-vitreal injection technic has been prescribed.

You may qualify if:

  • Naïve patients
  • Type 1 or type 2 Choroidal NeoVascularization (CNV)
  • Age ≥ 55 years
  • Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
  • Monitored monthly
  • Loading phase then bimonthly retreatment.
  • Signed Informed Consent.
  • Patient covered by the French Health Insurance

You may not qualify if:

  • Polypoidal choroidal vasculopathy
  • Type 3 neovascularization
  • Choroidal neovascularization attributable to causes other than AMD
  • Macular hematoma
  • Pigment epithelial detachment higher than 150µm
  • Fibrosis \> 50% lesion on fundus color photography, fibroglial scar
  • Media opacity annoying acquisition
  • Retinal vascular occlusion
  • Diabetic retinopathy
  • Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
  • Refractive error \>-6D
  • Active intraocular inflammation in the study eye
  • Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
  • Patient taking part in an interventional study at the time of enrolment.
  • Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Pellegrin, CHU de Bordeaux

Bordeaux, 33000, France

Location

CHI de Créteil

Créteil, 94000, France

Location

Hôpital La Croix Rousse

Lyon, 69004, France

Location

Hôpital Lariboisière, APHP

Paris, 75010, France

Location

Centre Ophtalmologique d'Imagerie et de Laser,

Paris, 75015, France

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

January 14, 2019

Study Start

April 4, 2018

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

FR(5)