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

Allergan

Status and phase: Completed; Phase 3

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: 350 µg Dexamethasone; Drug: 700 µg Dexamethasone; Other: Sham Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168298

206207-009

Details and patient eligibility

About

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

Enrollment: 668 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 18 years of age or older with macular edema resulting from retinal vein occlusion
• Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
• Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

• Known anticipated need for ocular surgery within next 12 months
• History of glaucoma or current high eye pressure requiring more than 1 medication
• Diabetic retinopathy
• Uncontrolled systemic disease
• Known steroid-responder
• Use of systemic steroids
• Use of warfarin/heparin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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668 participants in 3 patient groups

700 µg Dexamethasone

Experimental group

Description:

700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.

Treatment:

Drug: 700 µg Dexamethasone

350 µg Dexamethasone followed by 700 µg Dexamethasone

Experimental group

Description:

350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

Treatment:

Drug: 700 µg Dexamethasone

Drug: 350 µg Dexamethasone

Sham Injection followed by 700 µg Dexamethasone

Sham Comparator group

Description:

Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

Treatment:

Other: Sham Injection

Drug: 700 µg Dexamethasone