NCT00744666

Brief Summary

Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.

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
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1.7 years

First QC Date

August 29, 2008

Last Update Submit

August 4, 2009

Conditions

Vitreoretinal DiseaseOcular Hypertension

Keywords

Intravitreal triamcinolone acetonideSide-effectsOcular hypertensionGlaucomaPreventionVitreoretinal diseases requiring IVTA for treatment

Outcome Measures

Primary Outcomes (1)

  • To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.

    Monthly for 6 months

Secondary Outcomes (2)

  • Visual Acuity

    Monthly for 6 months

  • Incidence of other complications (cataract, retinal detachment, endophthalmitis)

    Monthly for 6 months

Study Arms (2)

1

EXPERIMENTAL

Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is \> or equal to 21 mmHg, then IVTA will be withheld. If the IOP \< 21mmHg, then patients will receive an injection of IVTA.

Drug: Prednisolone 1% topical eye drops

2

NO INTERVENTION

Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).

Interventions

Prednisolone 1% topical eye dropsDRUG

Prednisolone 1% 1gtt qid to the eye requiring IVTA

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment

You may not qualify if:

  • \< 18 years old
  • Pregnancy
  • Breast feeding
  • hx of uveitis
  • hx of neovascularization of the iris or anterior chamber angle
  • hx of ocular herpes simplex keratitis
  • hx of glaucoma
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

NOT YET RECRUITING

Related Publications (1)

  • Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.

    PMID: 12488256BACKGROUND

MeSH Terms

Conditions

Ocular HypertensionGlaucoma

Interventions

PrednisoloneOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Kenneth Eng, MD, FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Jeffery Gale, MD, FRCSC

    Hotel Dieu Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Eng, MD, FRCSC

CONTACT

416-480-4468kt_eng@hotmail.com

Jeffery Gale, MD, FRCSC

CONTACT

613-544-3400jeffgaleuwo@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

CA(4)