NCT01613963

Brief Summary

This is a study of visual outcomes in retinal disease that seeks to identify the causes of visual loss. This data will be used to predict which patients are at risk of losing vision and how they can be better treated.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

May 29, 2012

Last Update Submit

June 5, 2012

Conditions

Keywords

UveitisScleritis

Outcome Measures

Primary Outcomes (1)

  • Visual acuity at 5 years

    Best-corrected visual acuity at 5 years

    5 years

Secondary Outcomes (16)

  • Visual acuity at 10 years

    10 years

  • Source of referral

    Baseline

  • Laterality

    Baseline

  • Anatomical diagnosis

    Baseline

  • Aetiological diagnosis

    Baseline

  • +11 more secondary outcomes

Study Arms (1)

Patients with ocular inflammation

Patients with ocular inflammation

Drug: Immunosuppressive Agents

Interventions

Treatment with systemic corticosteroids and/or immunosuppressive agents Treatment with local corticosteroids and other drugs

Also known as: Prednisolone, Azathioprine, Methotrexate, Mycophenolate mofetil, Cyclosporine A, Infliximab, Adalimumab, Etanercept, Rituximab
Patients with ocular inflammation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ocular inflammation

You may qualify if:

  • patients with a diagnosis of ocular inflammation
  • patients with at least 6 months of follow-up

You may not qualify if:

  • patients without a diagnosis of ocular inflammation
  • patients with less than 6 months of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Moorfields Eye Hospital

London, London, EC1V 2PD, United Kingdom

Location

Royal Surrey County Hospital

Guildford, UK, GU2 7XX, United Kingdom

Location

MeSH Terms

Conditions

UveitisScleritis

Interventions

Immunosuppressive AgentsPrednisoloneAzathioprineMethotrexateMycophenolic AcidCyclosporineInfliximabAdalimumabEtanerceptRituximab

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesScleral Diseases

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesAminopterinPterinsPteridinesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, HumanizedImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsImmunoglobulin Constant RegionsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAntibodies, Monoclonal, Murine-Derived

Study Officials

  • Simon RJ Taylor, PhD FRCOphth

    Royal Surrey County Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer & Consultant Ophthalmic Surgeon

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 7, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations