Diabetic Macular OedemaNCT00427986
Clinical Study of the Effect of Intravenous Galactose on Diabetic Macular Oedema
A study testing Galactose, intravenous in people with Diabetic Macular Oedema, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- Galactose, intravenous
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Mar 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes
- clinically significant macular oedema
- visual acuity of minimum 40 letters by the ETDRS procedure
- retinal thickness of at least 250 microns in the foveal region on three retinal maps of the fast protocol of the StratusOCT at baseline or at least 300 microns outside the foveal region
- 1 disc area of oedema within 3000 microns from the foveal center on three retinal maps of the fast protocol of the StratusOCT at baseline
- maximal blood pressure 160/90 mmHg (mean of three measurements)
- informed consent
Who cannot join
- other ocular diseases or treatments, that can cause or influence the macular oedema, including prior laser photocoagulation. Traction oedema is allowed.
- glaucoma
- media opacities that significantly impairs the light reflection while scanning
- Pregnancy
- severe heart, lung and/or renal insufficiency (judged by the primary investigator)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57,
Glostrup Municipality, DK-2600
About this study
Official title: Diabetic Macular Oedema: Quantification of the Effect of Rising the Intracapillary Osmotic Pressure With Intravenous Galactose on the Retinal Thickness
The purpose of the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose.
Read the detailed description
Macular oedema (swelling of the retina) is a leading cause of severe visual loss and blindness in patients with diabetes. The oedema is caused by fluid accumulation in the retinal tissue from leaking capillaries and leads to an increase in the retinal thickness. Optical Coherence Tomography (OCT) has become the primary technique to estimate the retinal thickness objectively, and the scans can be performed without any discomfort to the patient after dilation of the pupils.
According to the Starling equation, a general basic physiologic rule, specific factors influence the fluid transport between the capillaries and the surrounding tissue. One of these factors is the balance between the large molecules within the vessel lumen and the surrounding tissue, e.g. the osmotic pressure balance. By changing the osmotic balance some drugs can reduce the fluid content in the tissue by extracting water from the tissue to the vessel lumen. Such a drug is galactose.
In the present study we examine, if treatment with intravenous galactose can reduce the retinal thickness in diabetic macular oedema evaluated by OCT during a three-hour monitoring. Galactose (0.5 mg/mL) is administered as 1 mL galactose per kg body weight + 10% with a maximum of 80 mL, and injection time is 5 min. If reduction of the thickness with galactose is found, it then confirms the application of the Starling osmotic forces on diabetic macular oedema. In the same time span series of venous blood samples are taken for analysis of plasma osmolarity and electrolytes. The systemic blood pressure is also monitored as well as the capillary glucose level.
As diurnal variations in the retinal thickness estimates potentially can influence the results, the OCT measurements and blood samples are repeated on a second day for each participant, without treatment with galactose for comparison. The order of two visits is given by randomisation.
Interim analysis will take place after inclusion of 15 to 20 patients to evaluate the need for inclusion of 45 patients.
- Conditions
- Diabetic Macular Oedema
- Being tested
- Galactose, intravenous
- Keywords
- Diabetes, Macular oedema, Osmosis, Galactose, Intravenous, Retinal thickness, Starling
- 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.
Galactose, intravenousDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness estimated by the fast protocol of the StratusOCT (0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 min).
Measured: three hours
Secondary outcomes (1)
Side effects during the three-hour examination period, to evaluate if caused by galactose per se or by an increase in intracapillary osmotic pressure.
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
Why it stopped: No sufficient increase in plasma osmolarity by galactose (one patient included)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Dorte Nellemann Thornit, MD, Principal investigator, Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427986
- Sponsor's protocol ID
- Dorte Nellemann, galactose
- Status last verified
- Jun 2007
- First submitted
- 25 Jan 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Macular Oedema: Quantification of the Effect of Rising the Intracapillary Osmotic Pressure With Intravenous Galactose on the Retinal Thickness
- ClinicalTrials.gov ID
- NCT00427986
- Acronym / sponsor ID
- Dorte Nellemann, galactose
- Conditions
- Diabetic Macular Oedema
- Keywords
- Diabetes, Macular oedema, Osmosis, Galactose, Intravenous, Retinal thickness, Starling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No sufficient increase in plasma osmolarity by galactose (one patient included)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 29 Jan 2007 (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 the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose.
Detailed description
Macular oedema (swelling of the retina) is a leading cause of severe visual loss and blindness in patients with diabetes. The oedema is caused by fluid accumulation in the retinal tissue from leaking capillaries and leads to an increase in the retinal thickness. Optical Coherence Tomography (OCT) has become the primary technique to estimate the retinal thickness objectively, and the scans can be performed without any discomfort to the patient after dilation of the pupils.
According to the Starling equation, a general basic physiologic rule, specific factors influence the fluid transport between the capillaries and the surrounding tissue. One of these factors is the balance between the large molecules within the vessel lumen and the surrounding tissue, e.g. the osmotic pressure balance. By changing the osmotic balance some drugs can reduce the fluid content in the tissue by extracting water from the tissue to the vessel lumen. Such a drug is galactose.
In the present study we examine, if treatment with intravenous galactose can reduce the retinal thickness in diabetic macular oedema evaluated by OCT during a three-hour monitoring. Galactose (0.5 mg/mL) is administered as 1 mL galactose per kg body weight + 10% with a maximum of 80 mL, and injection time is 5 min. If reduction of the thickness with galactose is found, it then confirms the application of the Starling osmotic forces on diabetic macular oedema. In the same time span series of venous blood samples are taken for analysis of plasma osmolarity and electrolytes. The systemic blood pressure is also monitored as well as the capillary glucose level.
As diurnal variations in the retinal thickness estimates potentially can influence the results, the OCT measurements and blood samples are repeated on a second day for each participant, without treatment with galactose for comparison. The order of two visits is given by randomisation.
Interim analysis will take place after inclusion of 15 to 20 patients to evaluate the need for inclusion of 45 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 1 or type 2 diabetes
- clinically significant macular oedema
- visual acuity of minimum 40 letters by the ETDRS procedure
- retinal thickness of at least 250 microns in the foveal region on three retinal maps of the fast protocol of the StratusOCT at baseline or at least 300 microns outside the foveal region
- 1 disc area of oedema within 3000 microns from the foveal center on three retinal maps of the fast protocol of the StratusOCT at baseline
Key exclusion criteria (5 listed)
- other ocular diseases or treatments, that can cause or influence the macular oedema, including prior laser photocoagulation. Traction oedema is allowed.
- glaucoma
- media opacities that significantly impairs the light reflection while scanning
- Pregnancy
- severe heart, lung and/or renal insufficiency (judged by the primary investigator)
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 |
|---|---|---|
| Galactose, intravenous | Drug | – |
Primary outcome
Retinal thickness estimated by the fast protocol of the StratusOCT (0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 min).
Time frame: three hours
1 secondary outcome
Side effects during the three-hour examination period, to evaluate if caused by galactose per se or by an increase in intracapillary osmotic pressure.
Time frame: Three hours
Results and safety
The study was stopped early (reason given: No sufficient increase in plasma osmolarity by galactose (one patient included)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
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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.
Dorte Nellemann Thornit, MD principal investigator
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galactose, intravenous in people with Diabetic Macular Oedema, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 7 inclusion and 5 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 26 Jun 2007. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No sufficient increase in plasma osmolarity by galactose (one patient included)). 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?
Retinal thickness estimated by the fast protocol of the StratusOCT (0, 2, 4, 8, 10, 15, 20, 30, 60, 90, 120 and 180 min). (time frame: three hours). 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 Jun 2007.