Hypertensive Patients With Retinal Vein OcclusionNCT01789437
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
A study testing Dexamethasone Intravitreal Implant (Ozuredex) in people with Hypertensive Patients With Retinal Vein Occlusion, run by Università degli Studi di Brescia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertensive Patients With Retinal Vein Occlusion
- What is being tested?
- Dexamethasone Intravitreal Implant (Ozuredex)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Dexamethasone Intravitreal Implant (Ozuredex)
- Keywords
- retinal vein occlusion, systemic hypertension, arteriolar diameter
- Medical subject headings
- Retinal Vein Occlusion, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Intravitreal Implant (Ozuredex)Device
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Intravitreal Implant | Active comparator | Not described Receives: Device: Dexamethasone Intravitreal Implant (Ozuredex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of outer arteriolar diameter
Measured: the primary endpoint was at 6 months
change of inner arteriolar diameter
Measured: 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.
Measured: Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Patients With Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
- Investigators
- Andrea Russo, Dr., Principal investigator, University of Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789437
- Sponsor's protocol ID
- DIAMETER-001
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
- ClinicalTrials.gov ID
- NCT01789437
- Acronym / sponsor ID
- DIAMETER-001
- Keywords
- retinal vein occlusion, systemic hypertension, arteriolar diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Intravitreal Implant | Active comparator | Device: Dexamethasone Intravitreal Implant (Ozuredex) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Intravitreal Implant (Ozuredex) | Device | Dexamethasone Intravitreal Implant |
Primary outcome
change of outer arteriolar diameter
Time frame: the primary endpoint was at 6 months
change of inner arteriolar diameter
Time frame: the primary endpoint was at 6 months
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Russo, Dr. principal investigator
University of Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Intravitreal Implant (Ozuredex) in people with Hypertensive Patients With Retinal Vein Occlusion, run by Università degli Studi di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of outer arteriolar diameter (time frame: the primary endpoint was at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.