Back to resultsSafety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Primary Purpose
Macular Edema
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
700 μg Dexamethasone
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
700 μg Dexamethasone
Sham
Arm Description
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Sham administered in the study eye on Day 1.
Outcomes
Primary Outcome Measures
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01660802
Brief Title
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 4, 2012 (Actual)
Primary Completion Date
March 31, 2014 (Actual)
Study Completion Date
May 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 μg Dexamethasone
Arm Type
Experimental
Arm Description
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham administered in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
700 μg Dexamethasone
Other Intervention Name(s)
Ozurdex®
Intervention Description
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham administered in the study eye on Day 1.
Primary Outcome Measure Information:
Title
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Baseline, 6 Months
Secondary Outcome Measure Information:
Title
Average Change From Baseline in BCVA in the Study Eye
Description
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.
Time Frame
Baseline, 6 Months
Title
Change From Baseline in BCVA in the Study Eye
Description
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.
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Title
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
Description
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.
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
29119239
Citation
Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.
Results Reference
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Learn more about this trial
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
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