NCT04689789

Brief Summary

To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

1.3 years

First QC Date

December 29, 2020

Last Update Submit

December 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls

    The parameters analyzed by optical coherence tomography angiography were: vessel density of superficial capillary plexus and deep capillary plexus

    15 months

Study Arms (3)

Patients with RAP

Patients with previous diagnosis of retinal angiomatous proliferation

Diagnostic Test: optical coherence tomography angiography

Patients with reticular pseudodrusen

Patients with previous diagnosis of reticular pseudodrusen

Diagnostic Test: optical coherence tomography angiography

Control group

Healthy eyes without actual and previous ocular diseases

Diagnostic Test: optical coherence tomography angiography

Interventions

optical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network

Control groupPatients with RAPPatients with reticular pseudodrusen

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participans were older than 65 years with diagnosis of age-related macular degeneration and in particular retinal angiomatous proliferation and reticular pseudodrusen. They did not present other ophthalmological diseases.

You may qualify if:

  • age older than 65 years
  • diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
  • absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • absence of significant lens opacities, low-quality OCT-A images.

You may not qualify if:

  • age older than 80 years
  • absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
  • presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • presence of significant lens opacities, low-quality OCT-A images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Gilda Cennamo

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 30, 2020

Study Start

September 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 20, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations