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
  Purpose

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 Intervention
Hypertensive Patients With Retinal Vein Occlusion
Device: Dexamethasone Intravitreal Implant (Ozuredex)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone Intravitreal Implant Device: Dexamethasone Intravitreal Implant (Ozuredex)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789437

Locations
Italy
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
  More Information

No publications provided

Responsible Party: Andrea Russo, Dr., Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01789437     History of Changes
Other Study ID Numbers: DIAMETER-001
Study First Received: February 7, 2013
Last Updated: February 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Brescia:
retinal vein occlusion
systemic hypertension
arteriolar diameter

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014