NCT06262737

Brief Summary

The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 30, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 16, 2024

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 17, 2023

Last Update Submit

February 15, 2024

Conditions

Macular DegenerationDiabetic Macular EdemaRetinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • OSDI

    Ocular Surface Disease Index: 12 questions treating of either the sensation, the visual impact and the environemental impact of the dry eye disease

    before the injection and at 1 day

Secondary Outcomes (6)

  • OSDI

    before the injection and at 1 week

  • HM

    before each injection

  • AM

    before each injection

  • NIBUT 1

    before each injection

  • NIBUT 2

    before each injection

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with retinal injury who will have 3 injections as the induction protocol (1 injection per month) for one eye and that didn't had any injection before.

You may qualify if:

  • Patient with exsudative age-related macular degeneration, diabetic macular edema or retinal vein occlusion
  • Patient with 3 ocular intravitreal injections of anti-VEGF in one eye

You may not qualify if:

  • pregnant or breastfeeding woman
  • intravitreal injection before the study
  • intravitreal injection in both eyes
  • allergy of betadine
  • guardianship patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Macular DegenerationRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Frederic CHIAMBARETTA

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

First Submitted

October 17, 2023

First Posted

February 16, 2024

Study Start

September 30, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

February 16, 2024

Record last verified: 2023-10

Locations

FR(1)