Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
This study has been completed.
Sponsor:
Università degli Studi di Brescia
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
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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 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 May 23, 2013