Diabetic Macular EdemaPhase 2NCT03533478
Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema
A Phase 2 study testing Oral treatment Alzer y Diamel in people with Diabetic Macular Edema, run by Catalysis SL at 1 site in Cuba.
Trial summary
Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Oral treatment Alzer y Diamel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCuba
- Study dates
- 1 Mar 2015to 30 Dec 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetics type 2 insulin treated.
- Age between 18 and 65 years.
- Glycosylated hemoglobin (HB A1c) <8% at the beginning of the investigation.
- Patients who express written voluntariness to enter the study with their signature of the informed consent document.
- If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.
Who cannot join
- Pregnancy and lactation.
- Age over 65 years.
- Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical).
- Opacity of the refractive media that hinders the ophthalmological examination.
- History of hypersensitivity to another similar product or one of its components.
- Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
- Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.
Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.
- Conditions
- Diabetic Macular Edema
- Being tested
- Oral treatment Alzer y Diamel, Placebo
- Keywords
- Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral treatment Alzer y DiamelDietary supplement
Alzer:
Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year.
Diamel:
Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year.
PlaceboDietary supplement
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | 32 patients with mild or moderate diabetic macular edema. Receives: Dietary Supplement: Oral treatment Alzer y Diamel |
| Group II | Placebo comparator | 32 patients with mild or moderate diabetic macular edema Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular retinal thickness
macular retinal measure
Measured: 1 year
Secondary outcomes (1)
Visual acuity
visual acuity test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Mar 2015
- Primary completion1 Dec 2018
- Study completion30 Dec 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juana Elvira Maciques Rodríguez, Dr., Principal investigator, National Institute of Endocrinology, Cuba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533478
- Sponsor's protocol ID
- ALZER-DIAMEL-EMD-2014
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.
- ClinicalTrials.gov ID
- NCT03533478
- Acronym / sponsor ID
- ALZER-DIAMEL-EMD-2014
- Conditions
- Diabetic Macular Edema
- Keywords
- Nutritional supplement, Diabetic Macular Edema, Diabetes, Alzer, Oxidative Stress, Diamel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 23 May 2018 (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.
Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Dietary Supplement: Oral treatment Alzer y Diamel32 patients with mild or moderate diabetic macular edema. |
| Group II | Placebo comparator | Dietary Supplement: Placebo32 patients with mild or moderate diabetic macular edema |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetics type 2 insulin treated.
- Age between 18 and 65 years.
- Glycosylated hemoglobin (HB A1c) <8% at the beginning of the investigation.
- Patients who express written voluntariness to enter the study with their signature of the informed consent document.
- If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.
Key exclusion criteria (7 listed)
- Pregnancy and lactation.
- Age over 65 years.
- Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical).
- Opacity of the refractive media that hinders the ophthalmological examination.
- History of hypersensitivity to another similar product or one of its components.
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 |
|---|---|---|
| Oral treatment Alzer y DiamelAlzer: Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year. Diamel: Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year. | Dietary supplement | Group I |
| PlaceboPlacebo treatment | Dietary supplement | Group II |
Primary outcome
Macular retinal thickness
Time frame: 1 year
macular retinal measure
1 secondary outcome
Visual acuity
Time frame: 1 year
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 22 May 2019.
- Individual participant dataSharing planned: Yes
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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.
Juana Elvira Maciques Rodríguez, Dr. principal investigator
National Institute of Endocrinology, Cuba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral treatment Alzer y Diamel in people with Diabetic Macular Edema, run by Catalysis SL at 1 site in Cuba.
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 7 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 22 May 2019. 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 Cuba. 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?
Macular retinal thickness (time frame: 1 year). 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 22 May 2019.