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

Sponsor
Università degli Studi di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT01789437
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
19.1
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dexamethasone Intravitreal Implant (Ozuredex)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexamethasone Intravitreal Implant

Device: Dexamethasone Intravitreal Implant (Ozuredex)

Outcome Measures

Primary Outcome Measures

  1. change of outer arteriolar diameter [the primary endpoint was at 6 months]

  2. change of inner arteriolar diameter [the primary endpoint was at 6 months]

Secondary Outcome Measures

  1. Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness. [Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spedali Civili di Brescia Brescia BS Italy 25124

Sponsors and Collaborators

  • Università degli Studi di Brescia

Investigators

  • Principal Investigator: Andrea Russo, Dr., University of Brescia, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Russo, Dr., Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01789437
Other Study ID Numbers:
  • DIAMETER-001
First Posted:
Feb 12, 2013
Last Update Posted:
Feb 12, 2013
Last Verified:
Feb 1, 2013
Keywords provided by Andrea Russo, Dr., Università degli Studi di Brescia
retinal vein occlusion
systemic hypertension
arteriolar diameter
Additional relevant MeSH terms:
Retinal Vein Occlusion
Dexamethasone

Study Results

No Results Posted as of Feb 12, 2013