Diabetic RetinopathyPhase 4Latano-2NCT01225653
Topical Application of Latanoprost in Diabetic Retinopathy
A Phase 4 study testing Latanoprost in people with Diabetic Retinopathy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 20 to 36 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Latanoprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Dec 2014
- Phase
- Phase 4
- 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 36 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-36 years old
- Diabetes mellitus with retinopathy
Who cannot join
- Pregnancy
- Previous ocular disease other than diabetic retinopathy
- General disease with possible influence on the eye
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Århus University Hospital
Aarhus, 8000
About this study
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.
Read the detailed description
The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.
The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.
- Conditions
- Diabetic Retinopathy
- Being tested
- Latanoprost
- Keywords
- Latanoprost, vasodilation, diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Also called No other names
Topical application
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost | Experimental | Topical treatment with latanoprost Receives: Drug: Latanoprost |
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diameter of retinal arterioles
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
Measured: 24 months
Secondary outcomes (1)
The severity of diabetic retinopathy
Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionDec 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Toke Bek, Professor, Principal investigator, Dept of Ophthalmology, Århus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225653
- Sponsor's protocol ID
- Latano-2
- Other IDs
- 2010-022433-29
- Acronym
- Latano-2
- Status last verified
- Dec 2014
- First submitted
- 20 Oct 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Latanoprost in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01225653
- Acronym / sponsor ID
- Latano-2 / Latano-2
- Conditions
- Diabetic Retinopathy
- Keywords
- Latanoprost, vasodilation, diabetic retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Oct 2010 (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.
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.
Detailed description
The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.
The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprost | Experimental | Drug: LatanoprostTopical treatment with latanoprost |
| Placebo | Placebo comparator | Drug: LatanoprostPlacebo arm |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 20-36 years old
- Diabetes mellitus with retinopathy
Key exclusion criteria (3 listed)
- Pregnancy
- Previous ocular disease other than diabetic retinopathy
- General disease with possible influence on the eye
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 |
|---|---|---|
| LatanoprostAlso: No other namesTopical application | Drug | Latanoprost, Placebo |
Primary outcome
The diameter of retinal arterioles
Time frame: 24 months
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
1 secondary outcome
The severity of diabetic retinopathy
Time frame: 24 months
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 18 Dec 2014.
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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.
Toke Bek, Professor principal investigator
Dept of Ophthalmology, Århus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latanoprost 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 3 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 18 Dec 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The diameter of retinal arterioles (time frame: 24 months). 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 18 Dec 2014.