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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Russo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01789437
First received: February 7, 2013
Last updated: February 8, 2013
Last verified: February 2013

February 7, 2013
February 8, 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 ] [ Designated as safety issue: No ]
  • change of inner arteriolar diameter [ Time Frame: the primary endpoint was at 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01789437 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01789437
DIAMETER-001
Yes
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