Diabetic Macular EdemaPhase 2NCT00768040
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
A Phase 2 study testing Aliskiren in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 12 sites in 2 countries.
Trial summary
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Aliskiren
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Sep 2008to Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes
- Diabetic macular edema
Who cannot join
- Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
- Recent laser photocoagulation in the study eye
- Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye
- Other protocol-defined inclusion/exclusion criteria applied
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
Georgia Retina
Atlanta, Georgia
Elman Retina Group
Baltimore, Maryland
Retina-Associates of Cleveland, Inc
Beachwood, Ohio
Joslin Clinic
Boston, Massachusetts, MA
Charlotte Eye, Ear, Nose and Throat Associate
Charlotte, North Carolina, NC
National Ophthalmic Research Institute
Fort Myers, Florida
Vitreo-Retinal Associates
Grand Rapids, Michigan
Retinal Consultants of Houston
Houston, Texas, TX
Retina-Vitreous Associates
Los Angeles, California
Retinal Consultants of Arizona
Phoenix, Arizona
Denmark2 sites
Novartis Investigative Site
Aarhus
Novartis Investigative Site
Copenhagen
About this study
Official title: A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema
- Conditions
- Diabetic Macular Edema
- Being tested
- Aliskiren, Placebo
- Keywords
- Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2
- Medical subject headings
- Diabetes Mellitus, Macular Edema, Diabetic Retinopathy, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called SPP100
300 mg once daily
PlaceboDrug
Matching placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren 300 mg | Experimental | Aliskiren 300 mg once daily for 12 weeks Receives: Drug: Aliskiren |
| Placebo | Placebo comparator | Matching placebo once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768040
- Sponsor's protocol ID
- CSPP100A2244
- Other IDs
- EudraCT 2008-00581-23
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2008
- Last updated
- 6 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00768040
- Acronym / sponsor ID
- CSPP100A2244
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema
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 |
|---|---|---|
| Aliskiren 300 mg | Experimental | Drug: AliskirenAliskiren 300 mg once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 or type 2 diabetes
- Diabetic macular edema
Key exclusion criteria (4 listed)
- Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
- Recent laser photocoagulation in the study eye
- Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye
- Other protocol-defined inclusion/exclusion criteria applied
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 |
|---|---|---|
| AliskirenAlso: SPP100300 mg once daily | Drug | Aliskiren 300 mg |
| PlaceboMatching placebo once daily | Drug | Placebo |
Primary outcome
Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
Time frame: Baseline to week 12
The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aliskiren in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 12 sites in 2 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, 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?
Yes. Results are posted in the registry (first posted 6 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment (time frame: Baseline to week 12). 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 6 Mar 2012.