NCT04193020

Brief Summary

Acute and chronic inflammatory eye diseases are difficult to diagnose and maintain quiescent with therapy. Proposed study is aimed to find on the one hand, novel factors for recurrence of the disease or remission of inflammation and evaluation of the impact of lifestyle and known factors on the other. Each patient is treated in accordance to the best of medical knowledge and guidelines for each disease. This prospective cohort study will enroll uveitic patients to the steroid only group (SG), combined (steroid and adjuvant drug) group (CG) or bilogic therapy group (BTG). At baseline, patient data are recorded using patient-reported outcome measures and clinical assessments (ophthalomology) on disease activity (clinical scales), quality of life, and lifestyle together with registry data on comorbidity and medication. During follow-up evaluation of a successful treatment outcome response will be based on clinical scales and most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients in different treatment group.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

December 7, 2019

Last Update Submit

April 16, 2021

Conditions

Uveitis

Outcome Measures

Primary Outcomes (3)

  • Treatment success

    Total number of treatment success in each group

    1 year

  • Recurrence time

    Time to the next recurrence after the treatment regimen introduction

    10 years

  • Severe visual loss

    Time and cause of severe visual loss

    10 years

Secondary Outcomes (7)

  • ETDRS Visual Acuity

    10 years

  • The SUN working group grading system for anterior chamber cells

    10 years

  • The SUN working group grading system for anterior chamber flare

    10 years

  • AREDS 2008 Clinical Lens Opacity Grading Procedure

    10 years

  • NIH grading system for vitreous cells

    10 years

  • +2 more secondary outcomes

Other Outcomes (10)

  • COVID-19 confirmed infection asymptomatic patient

    1 year

  • COVID-19 confirmed infection

    1 year

  • COVID-19 related acute respiratory distress syndrome (ARDS)

    1 year

  • +7 more other outcomes

Study Arms (3)

steroid only group (SG)

Other: Surveillance card

combined (steroid and adjuvant drug) group (CG)

Other: Surveillance card

bilogic therapy group (BTG)

Other: Surveillance card

Interventions

Surveillance cardOTHER

Surveillance card and additional examination to find novel markers and better assess the existing ones

bilogic therapy group (BTG)combined (steroid and adjuvant drug) group (CG)steroid only group (SG)

Eligibility Criteria

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

Any patient with a new diagnosis or a recurrence of uni or bilateral uveitis.

You may qualify if:

  • new diagnosis of uni or bilateral uveitis
  • recurrence of the diagnosed previously uni or bilateral uveitis

You may not qualify if:

  • not mentally able to reply the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Wroclaw, 54-622, Poland

RECRUITING

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Marta Misiuk-Hojło, Professor

    Medical University of Wrocław

    STUDY CHAIR

Central Study Contacts

Joanna Przeździecka-Dołyk, PhD

CONTACT

+49605693022joanna.przezdziecka-dolyk@umed.wroc.pl

Study Design

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

Study Record Dates

First Submitted

December 7, 2019

First Posted

December 10, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

PL(1)