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

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Choroidal Neovascularization; Age-Related Macular Degeneration

Treatments: Drug: Periocular injection of triamcinolone acetonide 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00305630

IND 64263

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)