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CompletedNCT00305630Updated Mar 22, 2006

Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)

A Phase 2/3 interventional study of Periocular injection of triamcinolone acetonide 40mg in Choroidal Neovascularization and Age-Related Macular Degeneration, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2006-03-22.

Sponsored by Johns Hopkins University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Choroidal Neovascularization
  • Age-Related Macular Degeneration

Keywords

  • Corticosteroids
  • Triamcinolone
  • Photodynamic therapy
  • Choroidal neovascularization
  • Age-related macular degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 100 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants

Interventions

  • DrugPeriocular injection of triamcinolone acetonide 40mg
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Safety

07

Study locations

2 sites
  • Johns Hopkins Univeristy School of Medicine
    Baltimore, Maryland 21287, United States
  • Oregon Health Science Univeristy
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00305630
Lead sponsor
Johns Hopkins University
Collaborators
Oregon Health and Science University
First posted
Mar 22, 2006
Start date
Jul 2002
Completion
Nov 2005
Last update
Mar 22, 2006

Study contacts

Douglas A Jabs, MD, MBA
study chair · Johns Hopkins University
Neil M Bressler, MD
principal investigator · Johns Hopkins Univeristy School of Medicine
David J Wilson, MD
principal investigator · Oregon Health and Science University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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