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

Study Identifier
206207-020
CT.gov Identifier
NCT01660802
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Macular Edema
    • Study Drug
  • 700 μg Dexamethasone
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Beijing, China
    Status
    Not applicable