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Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789437
First Posted: February 12, 2013
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrea Russo, Università degli Studi di Brescia
February 7, 2013
February 12, 2013
February 12, 2013
June 2011
June 2012   (Final data collection date for primary outcome measure)
  • change of outer arteriolar diameter [ Time Frame: the primary endpoint was at 6 months ]
  • change of inner arteriolar diameter [ Time Frame: the primary endpoint was at 6 months ]
Same as current
No Changes Posted
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. ]
Same as current
Not Provided
Not Provided
 
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
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.
Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Hypertensive Patients With Retinal Vein Occlusion
Device: Dexamethasone Intravitreal Implant (Ozuredex)
Active Comparator: Dexamethasone Intravitreal Implant
Intervention: Device: Dexamethasone Intravitreal Implant (Ozuredex)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
June 2012   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01789437
DIAMETER-001
Yes
Not Provided
Not Provided
Andrea Russo, Università degli Studi di Brescia
Università degli Studi di Brescia
Not Provided
Principal Investigator: Andrea Russo, Dr. University of Brescia, Italy
Università degli Studi di Brescia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP