Proliferative Diabetic RetinopathyNCT01946451
Gene Expression in Patients With Epiretinal Membranes
An observational study of Proliferative Diabetic Retinopathy, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- How many people
- Not given
- Where
- 1 sitePoland
- Study dates
- Jun 2012to Dec 2013
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population description: The blood and ERM samples were obtained from patients treated in the Department of Ophthalmology, University Hospital No. 5, Medical University of Silesia, Katowice, Poland. All subjects underwent a complete ophthalmic examination: best corrected visual acuity (BCVA), tonometry, slit lamp examination of anterior and posterior segment, optical coherence tomography (OCT) of the central retina.
Who may be able to join
- Caucasian race,
- both males and females,
- aged ≥ 55 years,
- suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).
- Presence of ERM was proven in optical coherence tomography (OCT) examination.
Who cannot join
- aged < 55 years,
- systemic connective tissue disease,
- active inflammatory process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gene Expression and Their Correlations in Patients With Idiopathic and Secondary Epiretinal Membranes in Proliferative Diabetic Retinopathy
The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- idiopathic epiretinal membranes, secondary epiretinal membranes
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 |
|---|---|---|
| Idiophatic ERMs | Not described | |
| Secondary ERMs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy.
Measured: The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorota Romaniuk, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946451
- Sponsor's protocol ID
- SilesianMU
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression and Their Correlations in Patients With Idiopathic and Secondary Epiretinal Membranes in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01946451
- Acronym / sponsor ID
- SilesianMU
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- idiopathic epiretinal membranes, secondary epiretinal membranes
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Sep 2013 (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 this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiophatic ERMs | – | – |
| Secondary ERMs | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population description: The blood and ERM samples were obtained from patients treated in the Department of Ophthalmology, University Hospital No. 5, Medical University of Silesia, Katowice, Poland. All subjects underwent a complete ophthalmic examination: best corrected visual acuity (BCVA), tonometry, slit lamp examination of anterior and posterior segment, optical coherence tomography (OCT) of the central retina.
Key inclusion criteria (5 listed)
- Caucasian race,
- both males and females,
- aged ≥ 55 years,
- suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).
- Presence of ERM was proven in optical coherence tomography (OCT) examination.
Key exclusion criteria (3 listed)
- aged < 55 years,
- systemic connective tissue disease,
- active inflammatory process
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
Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy.
Time frame: The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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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 Proliferative Diabetic Retinopathy, run by Medical University of Silesia at 1 site in Poland.
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 3 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 19 Sep 2013. 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 Poland. 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?
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?
Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy. (time frame: The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.). 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 19 Sep 2013.