Epiretinal MembraneNCT06232616
Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema
A study testing vitrectomy combined with intravitreal dexamethasone implant in people with Epiretinal Membrane, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- vitrectomy combined with intravitreal dexamethasone implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
- central retinal thickness >300 µm;
- cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
- ocular axial length less than 25.00 mm.
Who cannot join
- concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
- previous vitreoretinal surgery or intravitreal injection history;
- history of glaucoma or optic neuropathy of any kind;
- patients with uncontrolled systemic diseases or infectious diseases;
- patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema
The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:
- mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
- mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
- intraocular pressure throughout postoperative 24 weeks
- concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.
- Conditions
- Epiretinal Membrane
- Being tested
- vitrectomy combined with intravitreal dexamethasone implant
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy combined with intravitreal dexamethasone implantProcedure or surgery
The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | In this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant. Receives: Procedure: vitrectomy combined with intravitreal dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of visual acuity
mean change in best corrected visual acuity
Measured: from baseline to postoperative 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start11 Mar 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Sun, Ph.D., Study chair, Shanghai Eye Diseases Prevention & Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232616
- Sponsor's protocol ID
- YFZXYDK202401
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: mean change in best corrected visual acuity throughout the study until the results are published in the journal.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema
- ClinicalTrials.gov ID
- NCT06232616
- Acronym / sponsor ID
- YFZXYDK202401
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- 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 clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:
- mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
- mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
- intraocular pressure throughout postoperative 24 weeks
- concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Procedure: vitrectomy combined with intravitreal dexamethasone implantIn this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
- central retinal thickness >300 µm;
- cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
- ocular axial length less than 25.00 mm.
Key exclusion criteria (5 listed)
- concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
- previous vitreoretinal surgery or intravitreal injection history;
- history of glaucoma or optic neuropathy of any kind;
- patients with uncontrolled systemic diseases or infectious diseases;
- patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.
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 |
|---|---|---|
| vitrectomy combined with intravitreal dexamethasone implantThe dexamethasone implant will be injected into the vitreous cavity at the end of the surgery. | Procedure or surgery | Single arm |
Primary outcome
improvement of visual acuity
Time frame: from baseline to postoperative 24 weeks
mean change in best corrected visual acuity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. mean change in best corrected visual acuity throughout the study until the results are published in the journal.
Related trials for Epiretinal Membrane
Recruiting
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
Epiretinal Membrane
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
Recruiting
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Epiretinal Membrane, Dry Age Related Macular Degeneration
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.
Tao Sun, Ph.D. study chair
Shanghai Eye Diseases Prevention & Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy combined with intravitreal dexamethasone implant in people with Epiretinal Membrane, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 4 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: enrolling by invitation, as of the sponsor's last update on 24 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
improvement of visual acuity (time frame: from baseline to postoperative 24 weeks). 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 24 Apr 2025.