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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305630
• Other study ID #: IND 64263
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 20, 2006
• Last updated: March 20, 2006
• Start date: July 2002
• Est. completion date: November 2005

Study information

• Verified date: March 2006
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Wet Macular Degeneration

Intervention

Drug:
• Periocular injection of triamcinolone acetonide 40mg

Locations

Country	Name	City	State
United States	Johns Hopkins Univeristy School of Medicine	Baltimore	Maryland
United States	Oregon Health Science Univeristy	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary	Safety