Back to resultsDiameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Primary Purpose
Hypertensive Patients With Retinal Vein Occlusion
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dexamethasone Intravitreal Implant (Ozuredex)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertensive Patients With Retinal Vein Occlusion focused on measuring retinal vein occlusion, systemic hypertension, arteriolar diameter
Eligibility Criteria
Inclusion Criteria:
- ability to provide written informed consent and comply with study assessments for the full duration of the study;
- age > 20 years;
- decreased visual acuity as a result of clinically detectable ME associated with either CRVO or BRVO;
- the duration of macular edema was required to be between 4 and 24 weeks for both CRVO and BRVO;
- retinal thickness in the central subfield (as measured using optical coherence tomography) had to be > 350 µm in the study eye.
Exclusion Criteria:
- the exclusion criteria were as follows: diabetes; previous intravitreal anti-VEGF therapy or intravitreal steroid therapy; previous photodynamic therapy or focal laser; active retinal or optic disc neovascularization; active or history of choroidal neovascularization; presence of rubeosis iridis; any active infection; glaucoma, current ocular hypertension, or a history of steroid-induced intraocular pressure (IOP) increase in either eye; or concurrent eye disease in the study eye that could compromise visual acuity (e.g., choroidal neovascularization, diabetic retinopathy, epiretinal membrane).
Sites / Locations
- Spedali Civili di Brescia
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Dexamethasone Intravitreal Implant
Arm Description
Outcomes
Primary Outcome Measures
change of outer arteriolar diameter
change of inner arteriolar diameter
Secondary Outcome Measures
Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness.
Full Information
NCT ID
NCT01789437
First Posted
February 7, 2013
Last Updated
February 8, 2013
Sponsor
Università degli Studi di Brescia
1. Study Identification
Unique Protocol Identification Number
NCT01789437
Brief Title
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Official Title
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX) compared to a matched control group of normal eyes in non-hypertensive subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Patients With Retinal Vein Occlusion
Keywords
retinal vein occlusion, systemic hypertension, arteriolar diameter
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Intravitreal Implant
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Dexamethasone Intravitreal Implant (Ozuredex)
Primary Outcome Measure Information:
Title
change of outer arteriolar diameter
Time Frame
the primary endpoint was at 6 months
Title
change of inner arteriolar diameter
Time Frame
the primary endpoint was at 6 months
Secondary Outcome Measure Information:
Title
Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness.
Time Frame
Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ability to provide written informed consent and comply with study assessments for the full duration of the study;
age > 20 years;
decreased visual acuity as a result of clinically detectable ME associated with either CRVO or BRVO;
the duration of macular edema was required to be between 4 and 24 weeks for both CRVO and BRVO;
retinal thickness in the central subfield (as measured using optical coherence tomography) had to be > 350 µm in the study eye.
Exclusion Criteria:
the exclusion criteria were as follows: diabetes; previous intravitreal anti-VEGF therapy or intravitreal steroid therapy; previous photodynamic therapy or focal laser; active retinal or optic disc neovascularization; active or history of choroidal neovascularization; presence of rubeosis iridis; any active infection; glaucoma, current ocular hypertension, or a history of steroid-induced intraocular pressure (IOP) increase in either eye; or concurrent eye disease in the study eye that could compromise visual acuity (e.g., choroidal neovascularization, diabetic retinopathy, epiretinal membrane).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Russo, Dr.
Organizational Affiliation
University of Brescia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25124
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
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