Epiretinal MembranePhase 4NEPERMNCT07736690
Perioperative Topical Nepafenac After Epiretinal Membrane Surgery
A Phase 4 study testing Nepafenac 0.1% Ophthalmic Suspension and Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling in people with Epiretinal Membrane and Macular Pucker, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Pucker
- What is being tested?
- Nepafenac 0.1% Ophthalmic Suspension and Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Phase 4
- 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
- Adults aged 18 years or older.
- Diagnosis of idiopathic epiretinal membrane requiring pars plana vitrectomy.
- Best-corrected visual acuity impairment and/or metamorphopsia attributed to epiretinal membrane.
- Ability to provide written informed consent.
- Willingness to complete the scheduled follow-up examinations for 6 months.
Who cannot join
- - Previous vitreoretinal surgery in the study eye.
- Other retinal diseases that could affect visual or anatomical outcomes (e.g., diabetic retinopathy, retinal vein occlusion, age-related macular degeneration).
- Significant ocular trauma.
- Active ocular inflammation or infection.
- Advanced glaucoma or optic neuropathy affecting visual function.
- Media opacity preventing adequate retinal imaging.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: Perioperative Topical Nepafenac Enhances Early Anatomical and Functional Recovery After Epiretinal Membrane Surgery: A Prospective Comparative Study
This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. The study compares postoperative visual acuity, central macular thickness, and other clinical outcomes between patients treated with perioperative nepafenac and those receiving standard postoperative care.
Read the detailed description
Epiretinal membrane (ERM) surgery generally results in favorable anatomical outcomes; however, postoperative retinal inflammation may delay visual and structural recovery. Nepafenac is a topical nonsteroidal anti-inflammatory drug with excellent intraocular penetration and may reduce postoperative inflammation.
This prospective comparative study investigates the effect of perioperative topical nepafenac on early postoperative recovery following pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.
Participants were assigned to receive either perioperative topical nepafenac or standard postoperative treatment. The primary objective is to compare anatomical recovery, measured by optical coherence tomography, and functional recovery, assessed by best-corrected visual acuity. Secondary outcomes include changes in central macular thickness and postoperative complications.
The findings may help determine whether perioperative topical nepafenac provides additional benefit in improving early postoperative outcomes after epiretinal membrane surgery.
- Conditions
- Epiretinal Membrane, Macular Pucker
- Being tested
- Nepafenac 0.1% Ophthalmic Suspension, Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling
- Keywords
- Epiretinal Membrane, Pars Plana Vitrectomy, Nepafenac, Internal Limiting Membrane Peeling, Optical Coherence Tomography, Anti-inflammatory Therapy
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.1% Ophthalmic SuspensionDrug
Topical nepafenac 0.1% administered three times daily beginning one week before surgery and continued for four weeks after surgery, in addition to standard postoperative treatment.
Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingProcedure or surgery
Standard pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling performed for epiretinal membrane.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Nepafenac Group | Experimental | Participants received perioperative topical nepafenac in addition to pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. Receives: Drug: Nepafenac 0.1% Ophthalmic Suspension; Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling |
| Arm 2: Control Group | Active comparator | Participants underwent pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling without perioperative topical nepafenac. Receives: Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (BCVA)
To compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.
Measured: 6 months after surgery
Secondary outcomes (3)
Change in Central Macular Thickness (CMT)
To compare postoperative central macular thickness measured by spectral-domain optical coherence tomography between the two groups.
Measured: 6 months after surgery
Integrity of the Ellipsoid Zone
To evaluate postoperative restoration of the ellipsoid zone using optical coherence tomography.
Measured: 6 months after surgery
Postoperative Complications
To compare the incidence of postoperative complications between the two treatment groups.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
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.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel groups. One group received perioperative topical nepafenac in addition to standard surgical treatment, while the control group received standard surgical treatment without perioperative nepafenac. Outcomes were compared between the two groups during postoperative follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736690
- Sponsor's protocol ID
- E2-26-14982
- Acronym
- NEPERM
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Topical Nepafenac Enhances Early Anatomical and Functional Recovery After Epiretinal Membrane Surgery: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07736690
- Acronym / sponsor ID
- NEPERM / E2-26-14982
- Conditions
- Epiretinal Membrane, Macular Pucker
- Keywords
- Epiretinal Membrane, Pars Plana Vitrectomy, Nepafenac, Internal Limiting Membrane Peeling, Optical Coherence Tomography, Anti-inflammatory Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 30 Jul 2026 (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.
This prospective comparative study evaluates whether perioperative topical nepafenac improves early anatomical and functional recovery after pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. The study compares postoperative visual acuity, central macular thickness, and other clinical outcomes between patients treated with perioperative nepafenac and those receiving standard postoperative care.
Detailed description
Epiretinal membrane (ERM) surgery generally results in favorable anatomical outcomes; however, postoperative retinal inflammation may delay visual and structural recovery. Nepafenac is a topical nonsteroidal anti-inflammatory drug with excellent intraocular penetration and may reduce postoperative inflammation.
This prospective comparative study investigates the effect of perioperative topical nepafenac on early postoperative recovery following pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling.
Participants were assigned to receive either perioperative topical nepafenac or standard postoperative treatment. The primary objective is to compare anatomical recovery, measured by optical coherence tomography, and functional recovery, assessed by best-corrected visual acuity. Secondary outcomes include changes in central macular thickness and postoperative complications.
The findings may help determine whether perioperative topical nepafenac provides additional benefit in improving early postoperative outcomes after epiretinal membrane surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups. One group received perioperative topical nepafenac in addition to standard surgical treatment, while the control group received standard surgical treatment without perioperative nepafenac. Outcomes were compared between the two groups during postoperative follow-up.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Nepafenac Group | Experimental | Drug: Nepafenac 0.1% Ophthalmic Suspension, Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingParticipants received perioperative topical nepafenac in addition to pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling. |
| Arm 2: Control Group | Active comparator | Procedure: Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingParticipants underwent pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling without perioperative topical nepafenac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosis of idiopathic epiretinal membrane requiring pars plana vitrectomy.
- Best-corrected visual acuity impairment and/or metamorphopsia attributed to epiretinal membrane.
- Ability to provide written informed consent.
- Willingness to complete the scheduled follow-up examinations for 6 months.
Key exclusion criteria (6 listed)
- - Previous vitreoretinal surgery in the study eye.
- Other retinal diseases that could affect visual or anatomical outcomes (e.g., diabetic retinopathy, retinal vein occlusion, age-related macular degeneration).
- Significant ocular trauma.
- Active ocular inflammation or infection.
- Advanced glaucoma or optic neuropathy affecting visual function.
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 |
|---|---|---|
| Nepafenac 0.1% Ophthalmic SuspensionTopical nepafenac 0.1% administered three times daily beginning one week before surgery and continued for four weeks after surgery, in addition to standard postoperative treatment. | Drug | Arm 1: Nepafenac Group |
| Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane PeelingStandard pars plana vitrectomy with epiretinal membrane and internal limiting membrane peeling performed for epiretinal membrane. | Procedure or surgery | Arm 1: Nepafenac Group, Arm 2: Control Group |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: 6 months after surgery
To compare the change in best-corrected visual acuity (logMAR) between the perioperative nepafenac group and the control group following epiretinal membrane surgery.
3 secondary outcomes
Change in Central Macular Thickness (CMT)
Time frame: 6 months after surgery
Integrity of the Ellipsoid Zone
Time frame: 6 months after surgery
Postoperative Complications
Time frame: 6 months after surgery
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 30 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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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?
A Phase 4 study testing Nepafenac 0.1% Ophthalmic Suspension and Pars Plana Vitrectomy With Epiretinal Membrane and Internal Limiting Membrane Peeling in people with Epiretinal Membrane and Macular Pucker, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 30 Jul 2026. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (BCVA) (time frame: 6 months after surgery). 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 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.