Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

Allergan

Status and phase: Completed; Phase 3

Conditions: Macular Edema

Treatments: Other: Sham; Drug: 700 μg Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01660802

206207-020

Details and patient eligibility

About

This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Enrollment: 262 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion criteria

• History of glaucoma, ocular hypertension or optic nerve head change
• Any active bacterial, viral, parasitic, or fungal infections in either eye
• Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
• History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
• Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
• Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
• Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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262 participants in 2 patient groups

700 μg Dexamethasone

Experimental group

Description:

700 μg Dexamethasone intravitreal injection in the study eye on Day 1.

Treatment:

Drug: 700 μg Dexamethasone

Sham

Sham Comparator group

Description:

Sham administered in the study eye on Day 1.

Treatment:

Other: Sham

Drug: 700 μg Dexamethasone