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Completed

NCT Number: NCT01789437

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.

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Key information

Conditions

Hypertensive Patients With Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Hypertension Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spedali Civili di Brescia

Brescia, BS, 25124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dexamethasone Intravitreal Implant (Ozuredex)

Device

Primary outcomes

  1. change of outer arteriolar diameter

    Time frame: the primary endpoint was at 6 months

  2. change of inner arteriolar diameter

    Time frame: the primary endpoint was at 6 months

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 12, 2013
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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