NCT05108285

Brief Summary

The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

October 24, 2021

Last Update Submit

November 16, 2021

Conditions

Macular Neovascularisation

Outcome Measures

Primary Outcomes (1)

  • Dark halo measurement

    The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization.

    three years

Study Arms (1)

MNV group

Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA

Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)

Interventions

Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)DIAGNOSTIC_TEST

OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN

MNV group

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to evaluate which of two methods is able to detect in a peculiar way the dark halo around the MNV

You may qualify if:

  • age older than 55 years
  • diagnosis of macular neovascularization
  • absence of previous treatment with anti-Vegf injections
  • absence of other retinal vascular diseases

You may not qualify if:

  • age younger than 55 years
  • absence diagnosis of macular neovascularization
  • presence of previous treatment with anti-Vegf injections
  • presence of other retinal vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

Related Publications (1)

  • Fossataro F, Cennamo G, Montorio D, Clemente L, Costagliola C. Dark halo, a new biomarker in macular neovascularization: comparison between OCT angiography and ICGA-a pilot prospective study. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3205-3211. doi: 10.1007/s00417-022-05693-8. Epub 2022 May 6.

    PMID: 35522297DERIVED

Study Officials

  • Gilda Cennamo

    Università Federico II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2021

First Posted

November 4, 2021

Study Start

January 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 15, 2020

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

IT(1)