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OpenTrials
Completed

NCT Number: NCT00305630

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins Univeristy School of Medicine, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Periocular injection of triamcinolone acetonide 40mg

Drug

Primary outcomes

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

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy

Important dates

Study start
2002
Study completion
2005
First posted
Mar 22, 2006
Registry last updated
Mar 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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