Diabetic RetinopathyPhase 4NCT04140201
Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
A Phase 4 study testing Simvastatin 40mg, Fenofibrate 200mg and Omega 3 fatty acid in people with Diabetic Retinopathy, run by Alaa Hassan ElBaz.
Trial summary
The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Simvastatin 40mg, Fenofibrate 200mg and Omega 3 fatty acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- type 2diabetes
- Non proliferative diabetic retinopathy
Who cannot join
- Uncontrolled glycemic level
- proliferative diabetic retinopathy
About this study
Official title: Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients
Read the detailed description
The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score
- Conditions
- Diabetic Retinopathy
- Being tested
- Simvastatin 40mg, Fenofibrate 200mg, Omega 3 fatty acid
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
Also called Statin
Drugs that lower lipid level
Fenofibrate 200mgDrug
Also called Fibrate
Drugs that lower lipid levels
Omega 3 fatty acidDrug
Also called n3 FA
Drugs that lower lipid levels
| Study group | Role | What they receive |
|---|---|---|
| Receive oral hypoglycemic +omega 3 | Active comparator | Eicosapentanoic acid + standard treatment Receives: Drug: Omega 3 fatty acid |
| Receive oral hypoglycemic +statin | Active comparator | Simvastatin + standard treatment Receives: Drug: Simvastatin 40mg |
| Receive oral hypoglycemic +fibrate | Active comparator | Fenofibrate +standard treatment Receives: Drug: Fenofibrate 200mg |
| Receive oral hypoglycemic only | No intervention | Standard treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 80 participants will be evaluated through reduction of macular edema
assessed by ocular coherence tomography
Measured: 18 weeks
Secondary outcomes (1)
The 80 participants will be evaluated through reduction of cardiovascular risk
assessed by ASCVD risk score
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study startFeb 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionAug 2020 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Hassan ElBaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Hassan ElBaz, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140201
- Sponsor's protocol ID
- Diabetic Retinopathy
- Status last verified
- Jan 2020
- First submitted
- 21 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
- ClinicalTrials.gov ID
- NCT04140201
- Acronym / sponsor ID
- Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alaa Hassan ElBazUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- 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 investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients
Detailed description
The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Receive oral hypoglycemic +omega 3 | Active comparator | Drug: Omega 3 fatty acidEicosapentanoic acid + standard treatment |
| Receive oral hypoglycemic +statin | Active comparator | Drug: Simvastatin 40mgSimvastatin + standard treatment |
| Receive oral hypoglycemic +fibrate | Active comparator | Drug: Fenofibrate 200mgFenofibrate +standard treatment |
| Receive oral hypoglycemic only | No intervention | –Standard treatment only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- type 2diabetes
- Non proliferative diabetic retinopathy
Key exclusion criteria (2 listed)
- Uncontrolled glycemic level
- proliferative diabetic retinopathy
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 |
|---|---|---|
| Simvastatin 40mgAlso: StatinDrugs that lower lipid level | Drug | Receive oral hypoglycemic +statin |
| Fenofibrate 200mgAlso: FibrateDrugs that lower lipid levels | Drug | Receive oral hypoglycemic +fibrate |
| Omega 3 fatty acidAlso: n3 FADrugs that lower lipid levels | Drug | Receive oral hypoglycemic +omega 3 |
Primary outcome
The 80 participants will be evaluated through reduction of macular edema
Time frame: 18 weeks
assessed by ocular coherence tomography
1 secondary outcome
The 80 participants will be evaluated through reduction of cardiovascular risk
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 40mg, Fenofibrate 200mg and Omega 3 fatty acid in people with Diabetic Retinopathy, run by Alaa Hassan ElBaz.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
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 80 participants will be evaluated through reduction of macular edema (time frame: 18 weeks). 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 Jan 2020.