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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01660802
First received: August 7, 2012
Last updated: May 22, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Macular Edema
Drug: 700 μg Dexamethasone
Other: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Average Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in BCVA in the Study Eye [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 262
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Other Name: Ozurdex®
Sham Comparator: Sham
Sham administered in the study eye on Day 1.
Drug: 700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Other Name: Ozurdex®
Other: Sham
Sham administered in the study eye on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660802

Locations
China
Beijing, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01660802     History of Changes
Other Study ID Numbers: 206207-020
Study First Received: August 7, 2012
Results First Received: April 2, 2015
Last Updated: May 22, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015