NCT00305630

Brief Summary

Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

July 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
Last Updated

March 22, 2006

Status Verified

March 1, 2006

First QC Date

March 20, 2006

Last Update Submit

March 20, 2006

Conditions

Choroidal NeovascularizationAge-Related Macular Degeneration

Keywords

CorticosteroidsTriamcinolonePhotodynamic therapyChoroidal neovascularizationAge-related macular degeneration

Outcome Measures

Primary Outcomes (1)

  • Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.

Secondary Outcomes (1)

  • Safety

Interventions

Periocular injection of triamcinolone acetonide 40mgDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active choroidal neovascularization
  • Age related macular degeneration
  • Visual acuity 20/20 to 20/400

You may not qualify if:

  • Neovascular lesion \>6500 microns is greatest linear diameter
  • More than one prior photodynamic therapy treatment
  • Receiving systemic corticosteroids
  • Intraocular pressure \> 21 mm Hg or glaucoma medication use
  • History of glaucoma or history of ocular hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Univeristy School of Medicine

Baltimore, Maryland, 21287, United States

Location

Oregon Health Science Univeristy

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Choroidal NeovascularizationMacular Degeneration

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal Diseases

Study Officials

  • Douglas A Jabs, MD, MBA

    Johns Hopkins University

    STUDY CHAIR

  • Neil M Bressler, MD

    Johns Hopkins Univeristy School of Medicine

    PRINCIPAL INVESTIGATOR

  • David J Wilson, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

July 1, 2002

Study Completion

November 1, 2005

Last Updated

March 22, 2006

Record last verified: 2006-03

Locations

US(2)