Retinopathy, DiabeticPhase 2NCT01506895
A Phase 2 Clinical Study to Investigate Effects of Darapladib in Subjects With Diabetic Macular Edema
A Phase 2 study testing darapladib in people with Retinopathy, Diabetic, run by GlaxoSmithKline at 16 sites in 5 countries.
Trial summary
The purpose of this study is to characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinopathy, Diabetic
- What is being tested?
- darapladib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Feb 2012to Feb 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Confirmation of DME in the study eye by angiography
- Confirmation of retinal thickening in the study eye by study doctor
- Best corrected visual acuity score of 78-24 letters in the study eye
Who cannot join
- Additional eye disease in the study eye that could compromise study assessments
- Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
- Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
- Uncontrolled diabetes
- Certain types of liver disease
- Severe reduction in kidney function OR removal of a kidney OR kidney transplant
Show all 15Show fewer
- Blood pressure higher than normal despite lifestyle changes and treatment with medications
- Certain medications that may interfere with the study medication or eye assessments (these will be identified by the study doctor)
- Current severe heart failure
- Severe asthma that is poorly controlled with medication
- Previous severe allergic reaction to food, medications, drink, insect stings, etc
- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded
- Recent participation in a study of an investigational medication
- Any other reason the investigator deems the subject should not participate in the study
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Germany5 sites
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51109
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Münster, North Rhine-Westphalia, 48145
GSK Investigational Site
Ulm, Baden-Wurttemberg, 89075
Australia4 sites
GSK Investigational Site
East Melbourne, Victoria, 3002
GSK Investigational Site
Nedlands, Western Australia, 6009
GSK Investigational Site
Parramatta, New South Wales, 2150
GSK Investigational Site
Sydney, New South Wales, 2000
Italy4 sites
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Turin, Piedmont, 10122
Netherlands2 sites
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Rotterdam, 3011 BH
About this study
Official title: A Phase 2, Multi-national, Multi-centre, Double Masked, Randomised, Placebo Controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Darapladib Administered for 3 Months to Adult Subjects With Diabetic Macular Edema With Centre Involvement
The purpose of this study is to characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement.
Read the detailed description
This is a multi-national, multi-centre, randomised, double-masked, placebo-controlled, parallel-group study of repeat oral administration of 160 mg darapladib for 3 months in adult subjects with DME with centre involvement.
Eligible subjects will be randomised in a 2:1 ratio of active treatment to placebo, with the placebo group to allow a comparison of safety between treatment arms and to minimize the open label effect that can be observed with the visual acuity endpoint.
The primary aim of the study is to determine the effect of repeat doses of darapladib on the mean change from baseline of both best-corrected visual acuity (BCVA) and spectral domain OCT (SD-OCT) centre subfield. The study eye will be examined for changes over the life of the study. As this investigational treatment is systemic, the fellow eye may be examined in tandem to provide additional data.
- Conditions
- Retinopathy, Diabetic
- Being tested
- darapladib, placebo
- Keywords
- Diabetic Macular Edema
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darapladibDrug
Experimental compound 160 mg dose
placeboDrug
Placebo to match
| Study group | Role | What they receive |
|---|---|---|
| darapladib | Experimental | darapladib dosed at 160 mg once daily Receives: Drug: darapladib |
| placebo | Placebo comparator | Placebo to match once daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Acuity as measured by ETDRS BCVA
Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) after 3 months of treatment
Measured: 3 months
Change from baseline in Spectral Domain Optical Coherance Tomography
Mean change from baseline in SD-OCT after 3 months of treatment
Measured: 3 months
Secondary outcomes (5)
Changes in Retinal Anatomy
Changes in retinal anatomy as assessed by fluorescein angiography and fundus photography and SD-OCT in the study eye
Measured: 3 months
Safety and Tolerability as assessed by change from baseline in outcome measures
Safety and tolerability as assesed by: change from baseline in blood pressure and heart rate; assessed by change from baseline in complete ophthalmic exam and visual acuity; assessed by change from baseline in clinical laboratory tests; assessed by change from baseline in the collection of adverse events
Measured: 3 months
Changes in Pharmacodynamic LP-PLA2 enzyme inhibition
Changes over 3 months in the study of LP-PLA2 Enzyme inhibition as data permit
Measured: 3 months
Peak plasma concentration (Cmax) of study drug
Plasma Pharmacokinetic parameters of darapladib as data permit
Measured: 3 months
Plasma concentration versus time curve (AUC) of study drug
Plasma Pharmacokinetic parameters of darapladib as data permit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy, DiabeticStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506895
- Sponsor's protocol ID
- 115403
- Status last verified
- Nov 2016
- First submitted
- 21 Dec 2011
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-national, Multi-centre, Double Masked, Randomised, Placebo Controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Darapladib Administered for 3 Months to Adult Subjects With Diabetic Macular Edema With Centre Involvement
- ClinicalTrials.gov ID
- NCT01506895
- Acronym / sponsor ID
- 115403
- Conditions
- Retinopathy, Diabetic
- Keywords
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jan 2012 (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 characterize the systemic and ocular safety and tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of 3 months of repeat administration of oral darapladib in diabetic macular edema patients with centre involvement.
Detailed description
This is a multi-national, multi-centre, randomised, double-masked, placebo-controlled, parallel-group study of repeat oral administration of 160 mg darapladib for 3 months in adult subjects with DME with centre involvement.
Eligible subjects will be randomised in a 2:1 ratio of active treatment to placebo, with the placebo group to allow a comparison of safety between treatment arms and to minimize the open label effect that can be observed with the visual acuity endpoint.
The primary aim of the study is to determine the effect of repeat doses of darapladib on the mean change from baseline of both best-corrected visual acuity (BCVA) and spectral domain OCT (SD-OCT) centre subfield. The study eye will be examined for changes over the life of the study. As this investigational treatment is systemic, the fellow eye may be examined in tandem to provide additional data.
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 |
|---|---|---|
| darapladib | Experimental | Drug: darapladibdarapladib dosed at 160 mg once daily |
| placebo | Placebo comparator | Drug: placeboPlacebo to match once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A female subject is eligible to participate if she is of: Non-childbearing potential or child-bearing potential and agrees to contraception for an appropriate period of time
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Confirmation of DME in the study eye by angiography
- Confirmation of retinal thickening in the study eye by study doctor
- Best corrected visual acuity score of 78-24 letters in the study eye
Key exclusion criteria (15 listed)
- Additional eye disease in the study eye that could compromise study assessments
- Intraocular surgery, or laser photocoagulation in the study eye within 3 months of dosing
- Uncontrolled intraocular pressure in the study eye despite treatment with glaucoma medication
- Uncontrolled diabetes
- Certain types of liver disease
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 |
|---|---|---|
| darapladibExperimental compound 160 mg dose | Drug | darapladib |
| placeboPlacebo to match | Drug | placebo |
Primary outcome
Change from baseline in Visual Acuity as measured by ETDRS BCVA
Time frame: 3 months
Mean change from baseline in ETDRS Best Corrected Visual Acuity (BCVA) after 3 months of treatment
Change from baseline in Spectral Domain Optical Coherance Tomography
Time frame: 3 months
Mean change from baseline in SD-OCT after 3 months of treatment
5 secondary outcomes
Changes in Retinal Anatomy
Time frame: 3 months
Safety and Tolerability as assessed by change from baseline in outcome measures
Time frame: 3 months
Changes in Pharmacodynamic LP-PLA2 enzyme inhibition
Time frame: 3 months
Peak plasma concentration (Cmax) of study drug
Time frame: 3 months
Plasma concentration versus time curve (AUC) of study drug
Time frame: 3 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 21 Nov 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing darapladib in people with Retinopathy, Diabetic, run by GlaxoSmithKline at 16 sites in 5 countries.
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 15 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Australia, Italy, Netherlands, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in Visual Acuity as measured by ETDRS BCVA (time frame: 3 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 21 Nov 2016.