NCT05969418

Brief Summary

To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.

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 Jul 2023

Shorter than P25 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

July 1, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

19 days

First QC Date

July 23, 2023

Last Update Submit

May 21, 2024

Conditions

Macular Degeneration Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

  • The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc

    more than sixmonths

Study Arms (2)

Patients with neovascular macular degeneration

Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

healty patients matched age and sex without any ocular disease

Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

Interventions

Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameterDIAGNOSTIC_TEST

Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment

Patients with neovascular macular degenerationhealty patients matched age and sex without any ocular disease

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease

You may qualify if:

  • diagnosis of neovascular macular degeneration
  • absence of previous retinal surgery and congenital eye diseases.
  • absence of errors of refraction
  • absence of lens opacities
  • absence of low-quality OCT and OCTA images

You may not qualify if:

  • previous retinal surgery and congenital eye diseases
  • errors of refraction
  • lens opacities
  • low-quality OCT and OCTA images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, 80121, Italy

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ciro Costagliola, MD

    Federico II University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

July 1, 2023

Primary Completion

July 20, 2023

Study Completion

December 21, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

IT(1)