A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 2; Phase 1

Conditions: Macular Degeneration; Macular Edema; Branch Retinal Vein Occlusion

Treatments: Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308477

DX4001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Macular edema resulting from branch retinal vein condition
• The criteria for visual acuity and macular thickness are met

Exclusion criteria

• History of glaucoma
• Diabetic retinopathy
• Known steroid-responder
• Use of systemic steroids
• Use of Warfarin/Heparin

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)