Diabetic Macular EdemaPhase 2NCT00683176
Effect of Choline Fenofibrate (SLV348) on Macular Edema
A Phase 2 study testing Choline Fenofibrate in people with Diabetic Macular Edema, run by Abbott Products at 21 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME) Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Choline Fenofibrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 21 sitesin 10 countries
- Study dates
- Sep 2008to Mar 2011
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT;
- When laser treatment can be safely postponed by up to at least 3 months;
- With established T2DM and HbA1c < 10%;
- With systolic blood pressure (SBP) or diastolic blood pressure (DBP) < 160/90 mmHg;
- With documented elevated triglyceride levels (TG >=150 mg/dL [1.70 mmol/L]) at the screening visit or in the previous 3 months.
Who cannot join
- Previous laser photocoagulation;
- Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma;
- Poor visual acuity: visual acuity of 20/800
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
Bulgaria4 sites
Site Reference ID/Investigator# 54268
Sofia, 1000
Site Reference ID/Investigator# 54291
Sofia, 1233
Site Reference ID/Investigator# 54279
Sofia, 1408
Site Reference ID/Investigator# 54273
Sofia, 1517
Czechia4 sites
Site Reference ID/Investigator# 54267
Brno, 62500
Site Reference ID/Investigator# 54282
Ostrava-Vitkovice, 703 84
Site Reference ID/Investigator# 54283
Prague, 169 02
Site Reference ID/Investigator# 54270
Ústí nad Labem, 40113
Hungary3 sites
Site Reference ID/Investigator# 54269
Budapest, 1106
Site Reference ID/Investigator# 54277
Győr, H-9023
Site Reference ID/Investigator# 54275
Zalaegerszeg - Pozva, 8900
Germany2 sites
Site Reference ID/Investigator# 54263
Leipzig, 04103
Site Reference ID/Investigator# 54284
Münster, 48145
Poland2 sites
Site Reference ID/Investigator# 54265
Gdansk, 80-147
Site Reference ID/Investigator# 54266
Katowice, 40-760
Spain2 sites
Site Reference ID/Investigator# 54280
Madrid, 28002
Site Reference ID/Investigator# 54264
Santiago de Compostela, 15705
Denmark1 site
Site Reference ID/Investigator# 54274
Glostrup Municipality, 2600
Netherlands1 site
Site Reference ID/Investigator# 54293
Amsterdam, 1105 AZ
United Kingdom1 site
Site Reference ID/Investigator# 54271
Liverpool, L7 8XP
About this study
Official title: Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study
The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)
- Conditions
- Diabetic Macular Edema
- Being tested
- Choline Fenofibrate, Placebo
- Keywords
- Diabetic Macular Edema, OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline FenofibrateDrug
135 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Choline Fenofibrate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
Measured: 12 months
Secondary outcomes (4)
OCT variables (Retinal Thickness, Retinal thickening)
Measured: 12 months
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
Measured: 12 months
Lipids
Measured: 12 months
SBP/DBP, Urinary albumin excretion rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Jean-Claude Ansquer, MD, Study director, Abbott Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683176
- Sponsor's protocol ID
- S348.2.001
- Other IDs
- 2008-001064-37, 2008
- Status last verified
- Aug 2011
- First submitted
- 16 May 2008
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT00683176
- Acronym / sponsor ID
- S348.2.001
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, OCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 May 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 evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Choline Fenofibrate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT;
- When laser treatment can be safely postponed by up to at least 3 months;
- With established T2DM and HbA1c < 10%;
- With systolic blood pressure (SBP) or diastolic blood pressure (DBP) < 160/90 mmHg;
- With documented elevated triglyceride levels (TG >=150 mg/dL [1.70 mmol/L]) at the screening visit or in the previous 3 months.
Key exclusion criteria (3 listed)
- Previous laser photocoagulation;
- Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma;
- Poor visual acuity: visual acuity of 20/800
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 |
|---|---|---|
| Choline Fenofibrate135 mg | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
Time frame: 12 months
4 secondary outcomes
OCT variables (Retinal Thickness, Retinal thickening)
Time frame: 12 months
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
Time frame: 12 months
Lipids
Time frame: 12 months
SBP/DBP, Urinary albumin excretion rate
Time frame: 12 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 26 Aug 2011.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Dr Jean-Claude Ansquer, MD study director
Abbott Products
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Choline Fenofibrate in people with Diabetic Macular Edema, run by Abbott Products at 21 sites in 10 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 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 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Bulgaria, Czechia, Hungary, Germany, Poland and 5 more countries. 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?
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment) (time frame: 12 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 26 Aug 2011.