Epiretinal MembraneepitellNCT00902629
Epiretinal Fibrosis, Effect of Early Surgery
A study testing Early surgery in people with Epiretinal Membrane, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The goal of this randomized clinical trial is to investigate when it is optimal to treat the eye disease epiretinal fibrosis. Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Early surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Feb 2015
- 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
- Subjective loss of visual acuity and/or visual distortions
- Visual acuity more than or equal to 35 ETDRS letters (at 4 meter)
- Duration of symptoms Less than 13 months
- Metamorphopsia on a Amsler Grid
- Binocular vision disturbed
Who cannot join
- Diabetic eye symptoms
- Previous oculary surgery, except cataract
- Presence of hard drusen in age-related macular degeneration (AMD)
- Other serious eye diseases
- Patients unable to complete the follow up
- not legal guardian of themselves
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Eye department, Glostrup University hospital
Glostrup Municipality, Copenhagen, 2600
About this study
Official title: Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.
The goal of this randomized clinical trial is to investigate when it is optimal to treat the eye disease epiretinal fibrosis.
Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by early surgery compared to periodic controls until a continual loss of visual acuity has been ensure followed by surgery.
Read the detailed description
Epiretinal fibrosis is a disease of the macula, which affects the central retina, and there by the central vision. Epiretinal fibrosis is due to a growth of connective tissue on retinas surface.
From population studies shows that 15% of patients with epiretinal fibrosis will develop moderate to severe loss of visual acuity. Earlier studies have shown that surgery to remove the epiretinal membrane most often leads to improvements in visual acuity if not a normalization of this. The reason why not everyone has normalization of their visual acuity could be growth of connective in the deeper layers of the retina. This intraretinal fibrosis develops over time and is presumed to worsen with the duration of the condition.
In a patient with symptomatic epiretinal fibrosis and visual acuity over 0,4, the current clinical practice is to utilize the wait and see approach, where you hold of treatment until you have made sure that the patients visual acuity is declining. With the wait and see approach you avoid doing surgery on eyes that would have remained stable in their visual acuity. On the other hand will the same approach always ensure that we do surgery on eye that have deteriorated visual acuity, usually to a point of 0,1-0,3 and longer duration of disease.
Hence the results of delayed surgery are presumably worse than what could have been achieved by operating at an earlier point.
This project aims to investigate if you can give the patients a more favorable long term result by doing surgery earlier compared to the traditional wait and see approach.
This study is a prospective randomized clinical trial. We aim to include 60 patients, where 20 will be randomized to early surgery (intervention) and 40 to a close follow-up program(control). If the patients in the control group loss more than 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters during the follow-up of of they request surgery for their epiretinal fibrosis they will be offered the same operation as the intervention group.
The Intervention group is to have clear lens extraction if they are not already operated for cataract. This is within 4 weeks of inclusion, and another 4 weeks after this they will have their epiretinal fibrosis removed by pars plana vitrectomy.
There are clinical controls after 3,6,9 and 12 months after inclusion/surgery for both groups.
- Conditions
- Epiretinal Membrane
- Being tested
- Early surgery
- Keywords
- Epiretinal Fibrosis, Macular Pucker
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early surgeryProcedure or surgery
Intervention group contains patients randomized to receive surgery for their epiretinal fibrosis, at an earlier point than what the common clinical practice is now.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group contains the patients randomized for early treatment of their epiretinal fibrosis. Receives: Procedure: Early surgery |
| Control | No intervention | Control contains patients not randomized for early surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best corrected visual acuity, 12 months after enrollment
Measured: 12 months after enrollment
Secondary outcomes (3)
Retinal morphology in the control cohort, 12 months after enrollment
Measured: 12 months after enrollement
Change in subjective quality of life 12 month after enrollment.
Measured: 12 months after enrollment
Changes in visual field 12 months after enrollment
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Kofod, Glostrup University Hospital, Copenhagen
- Investigators
- Mads Kofod, MD, Principal investigator, Eye department, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902629
- Sponsor's protocol ID
- EPITELL
- Acronym
- epitell
- Status last verified
- Aug 2015
- First submitted
- 13 May 2009
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kofod M, Christensen UC, la Cour M. Deferral of surgery for epiretinal membranes: Is it safe? Results of a randomised controlled trial. Br J Ophthalmol. 2016 May;100(5):688-92. doi: 10.1136/bjophthalmol-2015-307301. Epub 2015 Sep 16.
PubMed 26377411
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Investigating the Longterm Results of Early vs. Delayed Surgery for Epiretinal Fibrosis.
- ClinicalTrials.gov ID
- NCT00902629
- Acronym / sponsor ID
- epitell / EPITELL
- Conditions
- Epiretinal Membrane
- Keywords
- Epiretinal Fibrosis, Macular Pucker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 May 2009 (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 goal of this randomized clinical trial is to investigate when it is optimal to treat the eye disease epiretinal fibrosis.
Hypothesis: In a population of patients with symptomatic idiopathic epiretinal fibrosis and visual acuity above 0.4, the best long term outcome measured by visual acuity is achieved by early surgery compared to periodic controls until a continual loss of visual acuity has been ensure followed by surgery.
Detailed description
Epiretinal fibrosis is a disease of the macula, which affects the central retina, and there by the central vision. Epiretinal fibrosis is due to a growth of connective tissue on retinas surface.
From population studies shows that 15% of patients with epiretinal fibrosis will develop moderate to severe loss of visual acuity. Earlier studies have shown that surgery to remove the epiretinal membrane most often leads to improvements in visual acuity if not a normalization of this. The reason why not everyone has normalization of their visual acuity could be growth of connective in the deeper layers of the retina. This intraretinal fibrosis develops over time and is presumed to worsen with the duration of the condition.
In a patient with symptomatic epiretinal fibrosis and visual acuity over 0,4, the current clinical practice is to utilize the wait and see approach, where you hold of treatment until you have made sure that the patients visual acuity is declining. With the wait and see approach you avoid doing surgery on eyes that would have remained stable in their visual acuity. On the other hand will the same approach always ensure that we do surgery on eye that have deteriorated visual acuity, usually to a point of 0,1-0,3 and longer duration of disease.
Hence the results of delayed surgery are presumably worse than what could have been achieved by operating at an earlier point.
This project aims to investigate if you can give the patients a more favorable long term result by doing surgery earlier compared to the traditional wait and see approach.
This study is a prospective randomized clinical trial. We aim to include 60 patients, where 20 will be randomized to early surgery (intervention) and 40 to a close follow-up program(control). If the patients in the control group loss more than 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters during the follow-up of of they request surgery for their epiretinal fibrosis they will be offered the same operation as the intervention group.
The Intervention group is to have clear lens extraction if they are not already operated for cataract. This is within 4 weeks of inclusion, and another 4 weeks after this they will have their epiretinal fibrosis removed by pars plana vitrectomy.
There are clinical controls after 3,6,9 and 12 months after inclusion/surgery for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Early surgeryIntervention group contains the patients randomized for early treatment of their epiretinal fibrosis. |
| Control | No intervention | –Control contains patients not randomized for early surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjective loss of visual acuity and/or visual distortions
- Visual acuity more than or equal to 35 ETDRS letters (at 4 meter)
- Duration of symptoms Less than 13 months
- Metamorphopsia on a Amsler Grid
- Binocular vision disturbed
Key exclusion criteria (6 listed)
- Diabetic eye symptoms
- Previous oculary surgery, except cataract
- Presence of hard drusen in age-related macular degeneration (AMD)
- Other serious eye diseases
- Patients unable to complete the follow up
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 |
|---|---|---|
| Early surgeryIntervention group contains patients randomized to receive surgery for their epiretinal fibrosis, at an earlier point than what the common clinical practice is now. | Procedure or surgery | Intervention |
Primary outcome
Change in best corrected visual acuity, 12 months after enrollment
Time frame: 12 months after enrollment
3 secondary outcomes
Retinal morphology in the control cohort, 12 months after enrollment
Time frame: 12 months after enrollement
Change in subjective quality of life 12 month after enrollment.
Time frame: 12 months after enrollment
Changes in visual field 12 months after enrollment
Time frame: 12 months after enrollment
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 13 Aug 2015.
- Derived from this study: PubMed 26377411Kofod M, Christensen UC, la Cour M. Deferral of surgery for epiretinal membranes: Is it safe? Results of a randomised controlled trial. Br J Ophthalmol. 2016 May;100(5):688-92. doi: 10.1136/bjophthalmol-2015-307301. Epub 2015 Sep 16.
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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.
Mads Kofod, MD principal investigator
Eye department, Glostrup University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early surgery in people with Epiretinal Membrane, 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 5 inclusion and 6 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 13 Aug 2015. 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 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?
Change in best corrected visual acuity, 12 months after enrollment (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902629, which also lists 1 linked publication.
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 13 Aug 2015.