Idiopathic Epimacular MembranePeelingNCT02146144
Prospective, Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery (Peeling)
A study testing ILM Peeling in people with Idiopathic Epimacular Membrane, run by Nantes University Hospital at 6 sites in France.
Trial summary
The epimacular membrane (EMM) is a degenerative condition associated with age, with a variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed by a peeling of the epimacular membrane using a microgripper. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Epimacular Membrane
- What is being tested?
- ILM Peeling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 6 sitesFrance
- Study dates
- 9 Sep 2014to 14 Mar 2022
- 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
- Adult patients (>18 years old) and female without childbearing potential or active contraception (intra-uterine device, contraceptive pill or contraceptive implant).
- Patients with an idiopathic symptomatic epimacular membrane; for patients with both eyes affected, the eye treated in the protocol will be the one which is most severely affected.
- Pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts
- Patients with social security
- Patients able to understand and follow the trial instructions
- Patients who have signed an informed consent
Who cannot join
- Patient with other retinal pathologies such as age related macular degeneration ("AMD"), retinal vein occlusion, diabetic retinopathy, glaucoma with macular visual field defect
- Patients with uveitis or history of uveitis
- Patients with any recent eye injuries or eye surgeries (<6 months)
- Patients participating in interventional clinical trial
- Pregnant or breast feeding women
- Vulnerable people : persons deprived of liberty; under trusteeship or under curatorship
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Dijon
Dijon
Clinique Sourdille
Nantes, 44000
CHU de Nantes
Nantes
Fondation Ophtalmologique A. de Rothschild
Paris
Hôpital Lariboisière (AP-HP)
Paris
Polyclinique de l'atlantique
Saint-Herblain, 44800
About this study
Official title: Prospective, Randomized, Controlled and Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery
The epimacular membrane (EMM) is a degenerative condition associated with age, with a variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed by a peeling of the epimacular membrane using a microgripper. Peeling of the internal limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is expected to increase the success rate of EMM surgery by reducing the risk of recurrence of EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not totally without consequence, it involves the risk of histological disorganization of the retina at the origin of one or several microscotomas, which are themselves responsible for a final visual discomfort. These microscotomas, resulting in the perception of somewhat black spots visible near the fixed point or the fixed image, may be highlighted by microperimetry and would be a loss of functional opportunity for the patient.
In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter the vision in half the patients. Furthermore, for those patients who are functionally affected by any such recurrence, a second epimacular membrane peeling surgery can be done.
The main objective of this study is to compare the difference in microscotoma(s) before surgery and 6 months later, between an "active ILM peeling" group and a "no ILM peeling" group. Given the more invasive nature of ILM peeling, the investigators believe that the rate of microscotomas in these patients is higher than those without peeling.
Read the detailed description
The visits for this trial are those planned for patients receiving EMM surgical operation, namely:
Selection/Inclusion visit : D-90 to D-7 This visit can be split in two according to the requirements of the investigator and/or the patient.
- Full information about the trial
- Verification of the inclusion and non-inclusion criteria
- Obtaining the signed informed consent (the same day or after a period of reflection)
- Medical and surgical history - *Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), microperimetry and pre-operative: "Patient discomfort" questionnaire (Appendix 7), an assessment of the appearance of the lens at the slit lamp, examination of the fundus after pupillary dilation, biomicroscopic examination of the anterior segment, retinal photography.
Surgery visit D0:
- List of all the surgical procedures
- Randomization for ILM peeling or not, in the operating room after dyeing of the ILM by the Membraneblue-Dual® (Picture of the macula). An anonymous video of the surgery will be sent to Nantes for centralized processing of the analysis of the EMM's grip areas.
To avoid bias, the follow-up visits will be made by an ophthalmologist and/or an orthoptist who will not know what action has been performed.
Follow-up visit M1 (1 month after the surgery ± 7 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.
- AE
Follow-up visit M6 (6 months after the surgery ± 15 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative: "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.
- AE End of study visit M12 (12 months after the surgery ± 15 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8), Biomicroscopic examination of the anterior segment, retinal photography.
- AE
- Conditions
- Idiopathic Epimacular Membrane
- Being tested
- ILM Peeling
- Keywords
- Idiopathic epimacular membrane, internal limiting membrane peeling, microscotomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM PeelingProcedure or surgery
common surgical procedure:
For phakic eyes with cataract • phacoemulsification and implantation of a posterior chamber intraocular lens
For all patients:
- Central and peripheral 25 Gauge vitrectomy
- dissection of the epimacular membrane
- injection of Membraneblue-Dual® according to protocol, wait of 1 minute with the infusion line closed, and then suction of surplus and washing of the vitreous cavity
- Intraoperative picture to see the possible spontaneous ILM peeling
- If no spontaneous ILM peeling, the patient will be randomized at the operating block
Specific surgical procedure:
- • Randomization into two groups:
- Arm 1: "no peeling", where the ILM peeling will not be made
- Arm 2: "active peeling", where the ILM peeling will be made
| Study group | Role | What they receive |
|---|---|---|
| no peeling | No intervention | where the ILM peeling will not be made |
| active peeling | Active comparator | where the ILM peeling will be made Receives: Procedure: ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in microscotomas between the inclusion visit and the visit at 6 months after surgery.
Analysis of the primary endpoint: the main criterion is the difference between the number of microscotomas measured before surgery and the number of microscotomas measured at 6 months (number between 0 and 29).
The mean difference will be calculated in each of two groups and compared using a mixed model of linear regression to take into account the stratification of the randomization at the center (the center will be considered as a random effect)
Measured: 6 months
Secondary outcomes (2)
Study of anatomical and functional changes of the retina
Number and types of microscotomas by microperimetry (before and after surgery)
Measured: 12 months
Study the rate of EMM recurrence (at M12) between the 2 groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start9 Sep 2014
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Epimacular 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramin Tadayoni, Pr, Principal investigator, Hopital LariboisièreCatherine Creuzot-Garchet, Pr, Principal investigator, Centre Hospitalier Universitaire DijonYannick Le Mer, Pr, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146144
- Sponsor's protocol ID
- RC14_0026
- Acronym
- Peeling
- Status last verified
- Feb 2023
- First submitted
- 7 Apr 2014
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ducloyer JB, Eude Y, Volteau C, Lebreton O, Bonissent A, Fossum P, Tadayoni R, Creuzot-Garcher CP, Le Mer Y, Perol J, Fortin J, Jobert A, Billaud F, Ivan C, Poinas A, Weber M; CFSR Research Net. Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING). Br J Ophthalmol. 2024 Dec 17;109(1):119-125. doi: 10.1136/bjo-2023-324990.
PubMed 38901960Ducloyer JB, Ivan J, Poinas A, Lebreton O, Bonissent A, Fossum P, Volteau C, Tadayoni R, Creuzot-Garchet C, Le Mer Y, Perol J, Fortin J, Chiffoleau A, Billaud F, Ivan C, Weber M. Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial. Trials. 2020 Jun 8;21(1):500. doi: 10.1186/s13063-020-04433-9.
PubMed 32513229
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled and Single-blind Study Assessing the Benefit/Risk Ratio of Internal Limiting Membrane (ILM) Peeling During Epimacular Membrane (EMM) Surgery
- ClinicalTrials.gov ID
- NCT02146144
- Acronym / sponsor ID
- Peeling / RC14_0026
- Conditions
- Idiopathic Epimacular Membrane
- Keywords
- Idiopathic epimacular membrane, internal limiting membrane peeling, microscotomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 23 May 2014 (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 epimacular membrane (EMM) is a degenerative condition associated with age, with a variable impact on vision. Treatment is surgery based and consists of a vitrectomy followed by a peeling of the epimacular membrane using a microgripper. Peeling of the internal limiting membrane (ILM) is an adjuvant action that is now frequently practiced and which is expected to increase the success rate of EMM surgery by reducing the risk of recurrence of EMM. Although ILM peeling does not seem to have an adverse effect on visual acuity, it is not totally without consequence, it involves the risk of histological disorganization of the retina at the origin of one or several microscotomas, which are themselves responsible for a final visual discomfort. These microscotomas, resulting in the perception of somewhat black spots visible near the fixed point or the fixed image, may be highlighted by microperimetry and would be a loss of functional opportunity for the patient.
In addition, recurrence of EMM, which the ILM peeling is supposed to diminish, does not alter the vision in half the patients. Furthermore, for those patients who are functionally affected by any such recurrence, a second epimacular membrane peeling surgery can be done.
The main objective of this study is to compare the difference in microscotoma(s) before surgery and 6 months later, between an "active ILM peeling" group and a "no ILM peeling" group. Given the more invasive nature of ILM peeling, the investigators believe that the rate of microscotomas in these patients is higher than those without peeling.
Detailed description
The visits for this trial are those planned for patients receiving EMM surgical operation, namely:
Selection/Inclusion visit : D-90 to D-7 This visit can be split in two according to the requirements of the investigator and/or the patient.
- Full information about the trial
- Verification of the inclusion and non-inclusion criteria
- Obtaining the signed informed consent (the same day or after a period of reflection)
- Medical and surgical history - *Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), microperimetry and pre-operative: "Patient discomfort" questionnaire (Appendix 7), an assessment of the appearance of the lens at the slit lamp, examination of the fundus after pupillary dilation, biomicroscopic examination of the anterior segment, retinal photography.
Surgery visit D0:
- List of all the surgical procedures
- Randomization for ILM peeling or not, in the operating room after dyeing of the ILM by the Membraneblue-Dual® (Picture of the macula). An anonymous video of the surgery will be sent to Nantes for centralized processing of the analysis of the EMM's grip areas.
To avoid bias, the follow-up visits will be made by an ophthalmologist and/or an orthoptist who will not know what action has been performed.
Follow-up visit M1 (1 month after the surgery ± 7 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.
- AE
Follow-up visit M6 (6 months after the surgery ± 15 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative: "Patient discomfort" questionnaire (Appendix 8). Biomicroscopic examination of the anterior segment, retinal photography.
- AE End of study visit M12 (12 months after the surgery ± 15 days)
- Examination: Visual acuity measured on the ETDRS scale, near vision (Parinaud), spectral domain optical coherence tomography (SD-OCT), Microscopic examination of the eye, microperimetry, fundus photography and post-operative "Patient discomfort" questionnaire (Appendix 8), Biomicroscopic examination of the anterior segment, retinal photography.
- AE
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no peeling | No intervention | –where the ILM peeling will not be made |
| active peeling | Active comparator | Procedure: ILM Peelingwhere the ILM peeling will be made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (>18 years old) and female without childbearing potential or active contraception (intra-uterine device, contraceptive pill or contraceptive implant).
- Patients with an idiopathic symptomatic epimacular membrane; for patients with both eyes affected, the eye treated in the protocol will be the one which is most severely affected.
- Pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts
- Patients with social security
- Patients able to understand and follow the trial instructions
Key exclusion criteria (6 listed)
- Patient with other retinal pathologies such as age related macular degeneration ("AMD"), retinal vein occlusion, diabetic retinopathy, glaucoma with macular visual field defect
- Patients with uveitis or history of uveitis
- Patients with any recent eye injuries or eye surgeries (<6 months)
- Patients participating in interventional clinical trial
- Pregnant or breast feeding women
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 |
|---|---|---|
| ILM Peelingcommon surgical procedure: For phakic eyes with cataract • phacoemulsification and implantation of a posterior chamber intraocular lens For all patients: * Central and peripheral 25 Gauge vitrectomy * dissection of the epimacular membrane * injection of Membraneblue-Dual® according to protocol, wait of 1 minute with the infusion line closed, and then suction of surplus and washing of the vitreous cavity * Intraoperative picture to see the possible spontaneous ILM peeling * If no spontaneous ILM peeling, the patient will be randomized at the operating block Specific surgical procedure: • • Randomization into two groups: * Arm 1: "no peeling", where the ILM peeling will not be made * Arm 2: "active peeling", where the ILM peeling will be made | Procedure or surgery | active peeling |
Primary outcome
the difference in microscotomas between the inclusion visit and the visit at 6 months after surgery.
Time frame: 6 months
Analysis of the primary endpoint: the main criterion is the difference between the number of microscotomas measured before surgery and the number of microscotomas measured at 6 months (number between 0 and 29). The mean difference will be calculated in each of two groups and compared using a mixed model of linear regression to take into account the stratification of the randomization at the center (the center will be considered as a random effect)
2 secondary outcomes
Study of anatomical and functional changes of the retina
Time frame: 12 months
Study the rate of EMM recurrence (at M12) between the 2 groups.
Time frame: 12 months
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 10 Feb 2023.
- Derived from this study: PubMed 38901960Ducloyer JB, Eude Y, Volteau C, Lebreton O, Bonissent A, Fossum P, Tadayoni R, Creuzot-Garcher CP, Le Mer Y, Perol J, Fortin J, Jobert A, Billaud F, Ivan C, Poinas A, Weber M; CFSR Research Net. Pros and cons of internal limiting membrane peeling during epiretinal membrane surgery: a randomised clinical trial with microperimetry (PEELING). Br J Ophthalmol. 2024 Dec 17;109(1):119-125. doi: 10.1136/bjo-2023-324990.
- Derived from this study: PubMed 32513229Ducloyer JB, Ivan J, Poinas A, Lebreton O, Bonissent A, Fossum P, Volteau C, Tadayoni R, Creuzot-Garchet C, Le Mer Y, Perol J, Fortin J, Chiffoleau A, Billaud F, Ivan C, Weber M. Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial. Trials. 2020 Jun 8;21(1):500. doi: 10.1186/s13063-020-04433-9.
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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.
Ramin Tadayoni, Pr principal investigator
Hopital Lariboisière
Catherine Creuzot-Garchet, Pr principal investigator
Centre Hospitalier Universitaire Dijon
Yannick Le Mer, Pr principal investigator
Fondation Ophtalmologique A. de Rothschild
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILM Peeling in people with Idiopathic Epimacular Membrane, run by Nantes University Hospital at 6 sites in France.
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 6 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
the difference in microscotomas between the inclusion visit and the visit at 6 months after surgery. (time frame: 6 months). 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 NCT02146144, which also lists 2 linked publications.
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 10 Feb 2023.