NCT04704609

Brief Summary

1\. Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change. Prospective use of changes in imaging quantification of inflammation (IQI) scores in determining treatment decisions both utilizing novel FA viewer software.

Trial Health

75
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
17mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress83%
Sep 2019Sep 2027

Study Start

First participant enrolled

September 22, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

7.6 years

First QC Date

October 21, 2020

Last Update Submit

March 2, 2026

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

  • Real Time Quantification of Ocular inflammation

    Perform observational study utilizing real-time quantification of ocular inflammation to determine minimal important change using FA viewer software.

    6 months

Secondary Outcomes (1)

  • Scoring ocular inflammation for clinical use

    6 months

Study Arms (1)

Imaging Analysis of patients with uveitis

Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist

Other: Standard of Care Imaging

Interventions

Standard of Care ImagingOTHER

We are collecting imaging that is standard of care for uveitis patients

Imaging Analysis of patients with uveitis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ocular inflammation.

You may qualify if:

  • Any patient with a diagnosis of uveitis, who is deemed active or recently active (6 months) by a uveitis specialist

You may not qualify if:

  • Poor view in fundus in both eyes which precludes image acquisition in those with posterior uveitis
  • Those with posterior uveitis, any allergy to fluorescein
  • Corneal opacities which prevent image acquisition
  • Inability to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Sunil K Srivastava, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 21, 2020

First Posted

January 11, 2021

Study Start

September 22, 2019

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(1)