Diabetic RetinopathyXAVOTNCT00619034
Pharmacological Intervention in Diabetic Retinopathy
A study testing Latanoprost, diclofenac and dorzolamide (eyedrops), Diclofenac and Dorzolamide in people with Diabetic Retinopathy, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Latanoprost, diclofenac and dorzolamide (eyedrops), Diclofenac and Dorzolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Dec 2010
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diabetes type 1 with moderate diabetic retinopathy/healthy
- Blood pressure < 135/85 mmHg
Who cannot join
- Eye disease (excluding diabetic retinopathy)
- Allergic
- Kidney disease
- Liver disease
- Severe asthma
- Heart disease
Show all 10Show fewer
- Hypertension arterial
- Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
- Pregnant and breastfeeding women and women who don't use secure contraception
- Persons who can't do without contact lens in the treated eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.
Read the detailed description
Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.
- Conditions
- Diabetic Retinopathy
- Being tested
- Latanoprost, diclofenac and dorzolamide (eyedrops), Diclofenac, Dorzolamide
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost, diclofenac and dorzolamide (eyedrops)Drug
Also called Xalatan, Voltaren ophtha, Trusopt
1 eyedrop twice daily in one week
DiclofenacDrug
Also called Voltaren ophtha
dicolfenac eyedrops twice daily i one eye
DorzolamideDrug
Also called Trusopt eyedrops
dorzolamide eyedrops twice daily, in one eye for one week
| Study group | Role | What they receive |
|---|---|---|
| latanoprost | Experimental | Medical intervention cross-over Receives: Drug: Latanoprost, diclofenac and dorzolamide (eyedrops) |
| diclofenac | Active comparator | medical intervention Receives: Drug: Diclofenac |
| dorzolamide | Experimental | dorzolamide eyedrops twice daily in one week Receives: Drug: Dorzolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of retinal blood vessels
Measured: one year
Secondary outcomes (1)
Influence on retinal blood flow in diabetes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Kathrine K Tilma, MD, Principal investigator, Department of Ophthalmology - Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619034
- Sponsor's protocol ID
- 2007-001697-84
- Other IDs
- XAVOT
- Acronym
- XAVOT
- Status last verified
- Dec 2010
- First submitted
- 7 Feb 2008
- Last updated
- 29 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
- ClinicalTrials.gov ID
- NCT00619034
- Acronym / sponsor ID
- XAVOT / 2007-001697-84
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Feb 2008 (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.
The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.
Detailed description
Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| latanoprost | Experimental | Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)Medical intervention cross-over |
| diclofenac | Active comparator | Drug: Diclofenacmedical intervention |
| dorzolamide | Experimental | Drug: Dorzolamidedorzolamide eyedrops twice daily in one week |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diabetes type 1 with moderate diabetic retinopathy/healthy
- Blood pressure < 135/85 mmHg
Key exclusion criteria (10 listed)
- Eye disease (excluding diabetic retinopathy)
- Allergic
- Kidney disease
- Liver disease
- Severe asthma
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 |
|---|---|---|
| Latanoprost, diclofenac and dorzolamide (eyedrops)Also: Xalatan, Voltaren ophtha, Trusopt1 eyedrop twice daily in one week | Drug | latanoprost |
| DiclofenacAlso: Voltaren ophthadicolfenac eyedrops twice daily i one eye | Drug | diclofenac |
| DorzolamideAlso: Trusopt eyedropsdorzolamide eyedrops twice daily, in one eye for one week | Drug | dorzolamide |
Primary outcome
Diameter of retinal blood vessels
Time frame: one year
1 secondary outcome
Influence on retinal blood flow in diabetes
Time frame: one year
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 29 Dec 2010.
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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.
Kathrine K Tilma, MD principal investigator
Department of Ophthalmology - Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost, diclofenac and dorzolamide (eyedrops), Diclofenac and Dorzolamide in people with Diabetic Retinopathy, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 10 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 29 Dec 2010. 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 Denmark. 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?
Diameter of retinal blood vessels (time frame: one year). 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 29 Dec 2010.