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Completed

NCT Number: NCT01660802

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

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.

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

700 μg Dexamethasone

Drug

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

Other names: Ozurdex®

SHAM

Other

Sham administered in the study eye on Day 1.

Primary outcomes

  1. Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, 6 Months

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Secondary outcomes

  1. Average Change From Baseline in BCVA in the Study Eye

    Time frame: Baseline, 6 Months

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

  2. Change From Baseline in BCVA in the Study Eye

    Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.

  3. Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye

    Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 9, 2012
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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