NCT05055973

Brief Summary

To suggest a novel classification of choroidal neovascular membrane based on optical coherence tomography angiography and to correlate morphological characteristics based on optical coherence tomography with clinical criteria of disease activity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

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

First Submitted

Initial submission to the registry

September 12, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 12, 2021

Last Update Submit

September 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphological characters of choroidal neovascular membrane

    To describe morphological criteria of choroidal neovascular membrane using optical coherence tomography angiography (OCTA).

    One year

Secondary Outcomes (1)

  • Correlation between morphological characters of choroidal neovascular membrane and disease activity

    One year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with choroidal neovascular membrane, naive or previously treated.

You may qualify if:

  • Patients with all types of CNV, previously treated or naïve.

You may not qualify if:

  • The presence of prominent media opacity.
  • Significant cataract.
  • Poor fixation.
  • Any other factor that interferes with obtaining good-quality OCT/OCTA images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Corvi F, Cozzi M, Barbolini E, Nizza D, Belotti M, Staurenghi G, Giani A. COMPARISON BETWEEN SEVERAL OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES AND INDOCYANINE GREEN ANGIOGRAPHY OF CHOROIDAL NEOVASCULARIZATION. Retina. 2020 May;40(5):873-880. doi: 10.1097/IAE.0000000000002471.

  • Parravano M, Querques L, Scarinci F, Giorno P, De Geronimo D, Gattegna R, Varano M, Bandello F, Querques G. Optical coherence tomography angiography in treated type 2 neovascularization undergoing monthly anti-VEGF treatment. Acta Ophthalmol. 2017 Aug;95(5):e425-e426. doi: 10.1111/aos.13180. Epub 2016 Aug 6. No abstract available.

  • Grossniklaus HE, Green WR. Choroidal neovascularization. Am J Ophthalmol. 2004 Mar;137(3):496-503. doi: 10.1016/j.ajo.2003.09.042.

  • Querques G, Corvi F, Querques L, Souied EH, Bandello F. Optical Coherence Tomography Angiography of Choroidal Neovascularization Secondary to Pathologic Myopia. Dev Ophthalmol. 2016;56:101-6. doi: 10.1159/000442800. Epub 2016 Mar 15.

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

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

Study Officials

  • Samir Y Saleh, PhD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Dalia M Elsebety, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 12, 2021

First Posted

September 24, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share