Diabetes MellitusPhase 3RETIPONNCT01208948
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema
A Phase 3 study testing 1,2 dithiolane 3 valeric acid in people with Diabetes Mellitus and Macular Edema, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema. Read more about this study
- Who is it for?
- Ages 45 to 68 years
- Conditions the study is for
- Diabetes Mellitus, Macular Edema
- What is being tested?
- 1,2 dithiolane 3 valeric acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2000to Dec 2005
- Phase
- Phase 3
- 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 45 to 68 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diabetes type II, mild non proliferative diabetic retinopathy,
- Microalbuminuria > 30 mg/L
Who cannot join
- Ophthalmic exclusion criteria
- severe non-proliferative or proliferative diabetic retinopathy
- Macular edema
- Eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage
- Amblyopia
- Best corrected visual acuity (VA) over 0.5
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- Glaucoma
- Patients with cataract surgery within a period of three months
- Other relevant retinal diseases
- Non-authorized interventional therapy of diabetic retinopathy (e.g. laser, kryo-coagulation, vitrectomy)
- General exclusion criteria
- Chronic administration of alpha lipoic acid or of more than five successive days during the last twelve months
- Known intolerance/hypersensitivity to alpha lipoic acid
- Type I diabetes mellitus
- Poor metabolic control with HbA1c >10.5 %/dl
- Late sequelae of diabetes with organic manifestation (e.g. dialysis in cases of renal insufficiency, history of kidney transplantation, creatinine > 1.6 mg/dl)
- Poorly controlled arterial hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 95 mmHg)
- Severe disturbances in lipid metabolism (triglycerides > 500 mg/dl or total cholesterol > 320 mg/dl)
- Unpermitted concomitant medication defined as any medicine with a potential interaction with alpha lipoic acid or with the effect of alpha lipoic acid were excluded as concomitant medication. These included aldose reductase inhibitors, substances promoting blood flow, anticoagulants apart from acetylsalicylic acid 500 mg/day and short-term treatment of diseases with the normal dose of acetylsalicylic acid, chronically and systemically administered corticosteroids, hormonal contraceptives
- Malignancies or life threatening diseases
- Drug or alcohol abuse
- Blood donation or blood loss greater than 500 ml) within the last 3 months
- Pregnancy or breast feeding
- Participation in a clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy
To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.
Read the detailed description
Randomised, double-blind, placebo controlled multicentre study. Patients were randomised to the treatment group with 600 mg ALA per day or the placebo group. At each examination we took stereo fundus photographs, HbA1c levels, and performed an ophthalmological examination. Primary endpoint of the study was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years.
- Conditions
- Diabetes Mellitus, Macular Edema
- Being tested
- 1,2 dithiolane 3 valeric acid
- Keywords
- macular edema, diabetes mellitus, prevention alpha lipoic acid
- Medical subject headings
- Diabetes Mellitus, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,2 dithiolane 3 valeric acidDrug
600 mg alpha lipoic acid per day
| Study group | Role | What they receive |
|---|---|---|
| Alpha lipoic acid 600 mg | Active comparator | Not described Receives: Drug: 1,2 dithiolane 3 valeric acid |
| placebo pill | Placebo comparator | Not described Receives: Drug: 1,2 dithiolane 3 valeric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
Measured: two years
Secondary outcomes (1)
The time to CSME development
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJul 2000
- Primary completionApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Michael W Ulbig, MD, Study director, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208948
- Sponsor's protocol ID
- DMP 77.1.99
- Acronym
- RETIPON
- Status last verified
- Sep 2010
- First submitted
- 23 Sep 2010
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01208948
- Acronym / sponsor ID
- RETIPON / DMP 77.1.99
- Conditions
- Diabetes Mellitus, Macular Edema
- Keywords
- macular edema, diabetes mellitus, prevention alpha lipoic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Jul 2000
- Primary completion
- Apr 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 24 Sep 2010 (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.
To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.
Detailed description
Randomised, double-blind, placebo controlled multicentre study. Patients were randomised to the treatment group with 600 mg ALA per day or the placebo group. At each examination we took stereo fundus photographs, HbA1c levels, and performed an ophthalmological examination. Primary endpoint of the study was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha lipoic acid 600 mg | Active comparator | Drug: 1,2 dithiolane 3 valeric acid |
| placebo pill | Placebo comparator | Drug: 1,2 dithiolane 3 valeric acid |
Who may qualify
- Ages
- 45 to 68 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes type II, mild non proliferative diabetic retinopathy,
- Microalbuminuria > 30 mg/L
Key exclusion criteria (24 listed)
- Ophthalmic exclusion criteria
- severe non-proliferative or proliferative diabetic retinopathy
- Macular edema
- Eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage
- Amblyopia
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 |
|---|---|---|
| 1,2 dithiolane 3 valeric acid600 mg alpha lipoic acid per day | Drug | Alpha lipoic acid 600 mg, placebo pill |
Primary outcome
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
Time frame: two years
1 secondary outcome
The time to CSME development
Time frame: two years
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 24 Sep 2010.
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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.
Michael W Ulbig, MD study director
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1,2 dithiolane 3 valeric acid in people with Diabetes Mellitus and Macular Edema, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 24 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 24 Sep 2010. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years (time frame: two years). 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 24 Sep 2010.