Diabetic Macular EdemaNCT01510691
Vitrectomy Retinal Oxygenation
An observational study of Diabetic Macular Edema, run by Stefan Sacu at 1 site in Austria.
Trial summary
Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Mar 2015
- Phase
- Observational
- 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
Study population: Group 1: 20 patients with macular edema following epiretinal membrane Group 2: 20 patients with persistent diabetic macular edema. Group 3: 20 patients with persistent macular edema following retinal vein occlusion
Who may be able to join
- male or female, at least 18 years of age.
- ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.
- persistent diabetic macular edema
- written informed consent
- female patients of childbearing potential must have a negative urine pregnancy test.
Who cannot join
- uncontrolled systemic disease
- symptoms of a clinically relevant illness in the 3 weeks before the first study day
- any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure
- history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.
- contraindication to pupil dilation.
- need for silicon oil or gas after the surgery
- advanced diabetic retinopathy with vitreoretinal tear and/or bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy
Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.
Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.
To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.
- Conditions
- Diabetic Macular Edema
- Keywords
- Oxygenation of the retinal vessels, vitroretinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epiretinal membrane | Not described | |
| diabetic macular edema | Not described | |
| vein occlusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Data
Visus, OCT
Measured: 6 months
Blood Flow Data
Oxygenation of retinal blood vessles and retinal blood flow
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Difficulties in recruiting participants
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Sacu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Sacu, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510691
- Sponsor's protocol ID
- VE-Oxygen-28062010
- Status last verified
- Jun 2020
- First submitted
- 11 Jan 2012
- Last updated
- 29 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy
- ClinicalTrials.gov ID
- NCT01510691
- Acronym / sponsor ID
- VE-Oxygen-28062010
- Conditions
- Diabetic Macular Edema
- Keywords
- Oxygenation of the retinal vessels, vitroretinal surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulties in recruiting participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stefan SacuUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jan 2012 (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.
Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.
Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.
To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epiretinal membrane | – | – |
| diabetic macular edema | – | – |
| vein occlusion | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: 20 patients with macular edema following epiretinal membrane Group 2: 20 patients with persistent diabetic macular edema. Group 3: 20 patients with persistent macular edema following retinal vein occlusion
Key inclusion criteria (5 listed)
- male or female, at least 18 years of age.
- ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.
- persistent diabetic macular edema
- written informed consent
- female patients of childbearing potential must have a negative urine pregnancy test.
Key exclusion criteria (7 listed)
- uncontrolled systemic disease
- symptoms of a clinically relevant illness in the 3 weeks before the first study day
- any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure
- history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.
- contraindication to pupil dilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Data
Time frame: 6 months
Visus, OCT
Blood Flow Data
Time frame: 6 months
Oxygenation of retinal blood vessles and retinal blood flow
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Stefan Sacu at 1 site in Austria.
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: withdrawn, as of the sponsor's last update on 29 Jun 2020. 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 Austria. 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 withdrawn before enrolling participants, so there are no results.
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?
Clinical Data (time frame: 6 months). The study lists 2 primary outcomes in all. 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 29 Jun 2020.