Proliferative VitreoretinopathyPhase 4NCT07162818
Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy
A Phase 4 study testing Nepafenac 0.1% eyedrops in people with Proliferative Vitreoretinopathy and Rhegmatogenous Retinal Detachment, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
PVR remains the major cause of surgical failure in RRD repair.1 Prompt surgical management is the standard therapy in RRD repair. However, in many places, vitreoretinal (VR) surgery facilities is limited, such as in Indonesia, where mainly located within referral hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
- What is being tested?
- Nepafenac 0.1% eyedrops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Apr 2021to 1 Dec 2021
- 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
- ARR with PVR grade A and B
- ARR onset more than 7 days and less than 1 month
- Macula off
- ARR patients with a minimum age of 18 years.
- Willing to follow the research stages and sign the informed consent.
Who cannot join
- ARR patients with media opacities that do not allow fundus examination
- History of undergoing intraocular surgery less than 3 months.
- ARR patients with comorbid eye diseases.
- ARR patients with systemic complications that make it impossible to undergo vitrectomy surgery.
- ARR sufferers who are known to have a history of allergies to the NSAID group.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital
Jakarta, Jakarta Pusat
About this study
PVR remains the major cause of surgical failure in RRD repair.1 Prompt surgical management is the standard therapy in RRD repair. However, in many places, vitreoretinal (VR) surgery facilities is limited, such as in Indonesia, where mainly located within referral hospitals. Until recently, there has been no recommended pharmacological therapy before surgery to prevent the formation of PVR in RRD. . Previous studies involving the use of pharmacological agents, such as anti-inflammatory and anti-proliferative agents, have been reported to prevent the development of PVR. Nepafenac 0.1% eye drops is a potent NSAID that has been proven effective in preventing macular edema in cases of post-cataract surgery and diabetic retinopathy. This study aims to compare the levels of vitreous inflammatory biomarkers in RRD following the administration of preoperative nepafenac 0.1%.
The inclusion criteria were patients of the age of 18 years old and above with macula-off RRD, grade A or B PVR, and RRD onset upon examination up to 1 month. The exclusion criteria included RRD patients with media opacification, a history of intraocular surgery in less than 3 months, other eye disease comorbidities (i.e., macular hole, epiretinal membrane), other systemic diseases, and a history of NSAID allergy.
Read the detailed description
Prospective subjects underwent Vital signs, an eye examination, fundus biomicroscopy, fundus photographs, and an Optical Coherent Tomography (OCT) scan of the macula were performed. This initial eye examination determined the degree of PVR before intervention was administered.
If they met the inclusion criteria, potential subjects were recruited and randomized, allocating the subjects to two groups: an intervention group with nepavenac 0.1% eye drops and a control group with Cenfresh® eye drops, administered 5 days before the vitrectomy. The medication labels were removed and replaced with the study labels.
The subjects were then prepared for surgery by undergoing blood tests, an EKG, and consultation with an anesthesiologist in the perioperative clinic of the Department of Anesthesia, RSCM/FKUI. The surgery was performed in the operating room of the Department of Ophthalmology, FKUI/RSCM Kirana, according to a predetermined schedule, which was after the subjects had used the eye drops for 5 days, 3 times daily. Written instructions and a daily checklist to record the medication drop schedule were provided to each subject.
On the day of surgery, a repeat fundus biomicroscopy examination, fundus photographs, and an OCT macular scan were performed to record the degree of PVR before the vitrectomy. Vitreous samples were taken during vitrectomy to assess vitreous biomarker levels.
After vitrectomy, all subjects underwent follow-up examinations on days 1, 7, and 28 to assess the surgical outcome. At each visit, routine examinations were performed, including vital signs, an eye examination, and fundus biomicroscopy. Fundus photographs and OCT scans were performed three times:
On the first visit during recruitment, the second visit on the day of surgery, and the final one on day 28 postoperatively. All examination results were recorded in the outpatient record at each visit.
- Being tested
- Nepafenac 0.1% eyedrops, Control (placebo) group
- Keywords
- Vitreous Inflammatory Biomarker, Nepafenac 0.1%, Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.1% eyedropsDrug
The study eye drops were nepavenac 0.1% eye drops (NEVANAC 0.1%®, Alcon Laboratories, Inc., Fort Worth, Texas). Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject.
Control (placebo) groupDrug
Cenfresh® eye drops (Cendo pharmaceutical, Indonesia) for the control group. Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac 0.1% eyedrops | Experimental | Nepafenac 0.1% is a topical NSAID pro-drug for the eye. Receives: Drug: Nepafenac 0.1% eyedrops |
| Control | Placebo comparator | Cenfresh® sterile eye drops in 5 mL packaging containing 5mg Carmellose sodium Receives: Drug: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostaglandin E2 (PGE2)
Vitreous samples were thawed and prostaglandin E2 (PGE2) levels were analyzed using the Prostaglandin E2 Monoclonal ELISA Kit (Cayman Chemical Company, Ann Arbor, MI) using a competitive ELISA according to the manufacturer's instructions. Briefly, serial dilutions of standards (7.8-1000 pg/mL) were prepared. Standards, controls, and vitreous samples were added to microplate wells coated with a specific polyclonal antibody against mouse IgG, followed by the addition of the acetylcholinesterase-PGE2 conjugate tracer and the PGE2 monoclonal antibody. The plates were incubated overnight at 40°C. During incubation, competition occurred between PGE-2 in the samples/standards and the PGE2 monoclonal antibody. The PGE-2 antibody complex bound to the polyclonal antibody against mouse IgG on the well walls. The plate was washed, then Ellman's reagent was added to each well of the microplate. The plate was covered and incubated at room temperature on an orbital shaker for 60 minutes. The color f
Measured: Through study completion, an average of 1 year
Transforming Growth Factor β1 (TGF-β1)
Vitreous samples were thawed and activated before the sandwich ELISA test using the Quantikine ELISA Human TGFβ-1 kit (R\&D Systems, MN, USA). Activation was performed by placing 40 μL of sample in a tube and adding 20 μL of 1N HCl, which was incubated for 10 minutes at room temperature. Next, the sample was neutralized by adding 20 μL of 1.2N NaOH and 0.5 M HEPES. Afterward, the sample was diluted 1:20 with RD5-53 calipers (a 1:4 dilution). Fifty μL of RD1-73 solution was added to each well of the microplate, followed by 50 μL of sample or standard, and incubated for 2 hours at room temperature. After the incubation period, the plate was washed three times with 400 μL of buffer. Afterward, anti-TGFb-1 conjugate was added to each well and incubated for another 2 hours at room temperature. After incubation, a wash was performed, then 100 μL of substrate solution was added, incubated for another 13 minutes at room temperature, protected from light, and the reaction was stopped by adding
Measured: Through study completion, an average of 1 year
Siklooksigenisase-2 (COX-2) Enzyme
Vitreous samples were thawed and activated before the sandwich ELISA assay using the Human Cyclooxygenase 2 (COX-2) kit according to the protocol. The vitreous samples were added to the wells of a microtiter plate coated with a monoclonal antibody against COX-2. If COX-2 is present in the sample, it will bind to the antibody. To quantitatively determine the amount of COX-2 in the sample, standards with varying concentrations of COX-2 were added. After incubation, the COX-2 antibody on the well walls binds to the COX-2 in the sample or standard. After washing to remove any unbound components, a horseradish peroxidase (HRP)-conjugated polyclonal antibody was added. The microtiter plate was incubated and then washed. Next, substrate solution was added to each well of the microtiter plate. The HRP enzyme and substrate were allowed to react for a short incubation period. Only wells containing COX-2 showed a color change due to binding to the HRP-conjugated antibody. The enzyme-substrate re
Measured: Through study completion, an average of 1 year
Macrophage Cell Count
The number of macrophages in vitreous samples was measured using flow cytometry, utilizing CD14 as a monocyte/macrophage marker. Pure vitreous samples were prepared according to a modification of the protocol adopted for cytology samples at the Faculty of Medicine, University of Indonesia (FKUI) Integrated Laboratory. After incubation for 10 minutes at room temperature in the dark, the samples were centrifuged for 5 minutes at 1500 rpm. The supernatant was discarded and washed with 2.5 mL of buffer solution. Antibody was added, and the samples were then incubated in the dark at room temperature for 20 minutes. After 20 minutes, excess antibody was washed away with buffer solution. Flow cytometry was performed using a FACSCanto II flow cytometer (Becton Dickinson, San Jose, CA). The results were analyzed using the FACSDiva program.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start28 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative VitreoretinopathyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will compare the levels of vitreous inflammatory biomarkers in rhegmatogenous retinal detachment (RRD) with proliferative vitreoretinopathy (PVR), following the administration of pre-vitrectomy nepafenac 0.1%, as a method to prevent the progression of PVR.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.dr. Ari Djatikusumo, Sp. M(K)., Universitas Indonesia
- Investigators
- Ari Djatikusumo, MD, Principal investigator, Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162818
- Sponsor's protocol ID
- 21-01-0081
- Other IDs
- PUTI Saintekes 2022 Grant
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy
- ClinicalTrials.gov ID
- NCT07162818
- Acronym / sponsor ID
- 21-01-0081
- Keywords
- Vitreous Inflammatory Biomarker, Nepafenac 0.1%, Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Sep 2025 (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.
PVR remains the major cause of surgical failure in RRD repair.1 Prompt surgical management is the standard therapy in RRD repair. However, in many places, vitreoretinal (VR) surgery facilities is limited, such as in Indonesia, where mainly located within referral hospitals. Until recently, there has been no recommended pharmacological therapy before surgery to prevent the formation of PVR in RRD. . Previous studies involving the use of pharmacological agents, such as anti-inflammatory and anti-proliferative agents, have been reported to prevent the development of PVR. Nepafenac 0.1% eye drops is a potent NSAID that has been proven effective in preventing macular edema in cases of post-cataract surgery and diabetic retinopathy. This study aims to compare the levels of vitreous inflammatory biomarkers in RRD following the administration of preoperative nepafenac 0.1%.
The inclusion criteria were patients of the age of 18 years old and above with macula-off RRD, grade A or B PVR, and RRD onset upon examination up to 1 month. The exclusion criteria included RRD patients with media opacification, a history of intraocular surgery in less than 3 months, other eye disease comorbidities (i.e., macular hole, epiretinal membrane), other systemic diseases, and a history of NSAID allergy.
Detailed description
Prospective subjects underwent Vital signs, an eye examination, fundus biomicroscopy, fundus photographs, and an Optical Coherent Tomography (OCT) scan of the macula were performed. This initial eye examination determined the degree of PVR before intervention was administered.
If they met the inclusion criteria, potential subjects were recruited and randomized, allocating the subjects to two groups: an intervention group with nepavenac 0.1% eye drops and a control group with Cenfresh® eye drops, administered 5 days before the vitrectomy. The medication labels were removed and replaced with the study labels.
The subjects were then prepared for surgery by undergoing blood tests, an EKG, and consultation with an anesthesiologist in the perioperative clinic of the Department of Anesthesia, RSCM/FKUI. The surgery was performed in the operating room of the Department of Ophthalmology, FKUI/RSCM Kirana, according to a predetermined schedule, which was after the subjects had used the eye drops for 5 days, 3 times daily. Written instructions and a daily checklist to record the medication drop schedule were provided to each subject.
On the day of surgery, a repeat fundus biomicroscopy examination, fundus photographs, and an OCT macular scan were performed to record the degree of PVR before the vitrectomy. Vitreous samples were taken during vitrectomy to assess vitreous biomarker levels.
After vitrectomy, all subjects underwent follow-up examinations on days 1, 7, and 28 to assess the surgical outcome. At each visit, routine examinations were performed, including vital signs, an eye examination, and fundus biomicroscopy. Fundus photographs and OCT scans were performed three times:
On the first visit during recruitment, the second visit on the day of surgery, and the final one on day 28 postoperatively. All examination results were recorded in the outpatient record at each visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will compare the levels of vitreous inflammatory biomarkers in rhegmatogenous retinal detachment (RRD) with proliferative vitreoretinopathy (PVR), following the administration of pre-vitrectomy nepafenac 0.1%, as a method to prevent the progression of PVR.
| Arm | Type | Receives |
|---|---|---|
| Nepafenac 0.1% eyedrops | Experimental | Drug: Nepafenac 0.1% eyedropsNepafenac 0.1% is a topical NSAID pro-drug for the eye. |
| Control | Placebo comparator | Drug: Control (placebo) groupCenfresh® sterile eye drops in 5 mL packaging containing 5mg Carmellose sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ARR with PVR grade A and B
- ARR onset more than 7 days and less than 1 month
- Macula off
- ARR patients with a minimum age of 18 years.
- Willing to follow the research stages and sign the informed consent.
Key exclusion criteria (5 listed)
- ARR patients with media opacities that do not allow fundus examination
- History of undergoing intraocular surgery less than 3 months.
- ARR patients with comorbid eye diseases.
- ARR patients with systemic complications that make it impossible to undergo vitrectomy surgery.
- ARR sufferers who are known to have a history of allergies to the NSAID group.
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% eyedropsThe study eye drops were nepavenac 0.1% eye drops (NEVANAC 0.1%®, Alcon Laboratories, Inc., Fort Worth, Texas). Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject. | Drug | Nepafenac 0.1% eyedrops |
| Control (placebo) groupCenfresh® eye drops (Cendo pharmaceutical, Indonesia) for the control group. Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject. | Drug | Control |
Primary outcome
Prostaglandin E2 (PGE2)
Time frame: Through study completion, an average of 1 year
Vitreous samples were thawed and prostaglandin E2 (PGE2) levels were analyzed using the Prostaglandin E2 Monoclonal ELISA Kit (Cayman Chemical Company, Ann Arbor, MI) using a competitive ELISA according to the manufacturer's instructions. Briefly, serial dilutions of standards (7.8-1000 pg/mL) were prepared. Standards, controls, and vitreous samples were added to microplate wells coated with a specific polyclonal antibody against mouse IgG, followed by the addition of the acetylcholinesterase-PGE2 conjugate tracer and the PGE2 monoclonal antibody. The plates were incubated overnight at 40°C. During incubation, competition occurred between PGE-2 in the samples/standards and the PGE2 monoclonal antibody. The PGE-2 antibody complex bound to the polyclonal antibody against mouse IgG on the well walls. The plate was washed, then Ellman's reagent was added to each well of the microplate. The plate was covered and incubated at room temperature on an orbital shaker for 60 minutes. The color f
Transforming Growth Factor β1 (TGF-β1)
Time frame: Through study completion, an average of 1 year
Vitreous samples were thawed and activated before the sandwich ELISA test using the Quantikine ELISA Human TGFβ-1 kit (R\&D Systems, MN, USA). Activation was performed by placing 40 μL of sample in a tube and adding 20 μL of 1N HCl, which was incubated for 10 minutes at room temperature. Next, the sample was neutralized by adding 20 μL of 1.2N NaOH and 0.5 M HEPES. Afterward, the sample was diluted 1:20 with RD5-53 calipers (a 1:4 dilution). Fifty μL of RD1-73 solution was added to each well of the microplate, followed by 50 μL of sample or standard, and incubated for 2 hours at room temperature. After the incubation period, the plate was washed three times with 400 μL of buffer. Afterward, anti-TGFb-1 conjugate was added to each well and incubated for another 2 hours at room temperature. After incubation, a wash was performed, then 100 μL of substrate solution was added, incubated for another 13 minutes at room temperature, protected from light, and the reaction was stopped by adding
Siklooksigenisase-2 (COX-2) Enzyme
Time frame: Through study completion, an average of 1 year
Vitreous samples were thawed and activated before the sandwich ELISA assay using the Human Cyclooxygenase 2 (COX-2) kit according to the protocol. The vitreous samples were added to the wells of a microtiter plate coated with a monoclonal antibody against COX-2. If COX-2 is present in the sample, it will bind to the antibody. To quantitatively determine the amount of COX-2 in the sample, standards with varying concentrations of COX-2 were added. After incubation, the COX-2 antibody on the well walls binds to the COX-2 in the sample or standard. After washing to remove any unbound components, a horseradish peroxidase (HRP)-conjugated polyclonal antibody was added. The microtiter plate was incubated and then washed. Next, substrate solution was added to each well of the microtiter plate. The HRP enzyme and substrate were allowed to react for a short incubation period. Only wells containing COX-2 showed a color change due to binding to the HRP-conjugated antibody. The enzyme-substrate re
Macrophage Cell Count
Time frame: Through study completion, an average of 1 year
The number of macrophages in vitreous samples was measured using flow cytometry, utilizing CD14 as a monocyte/macrophage marker. Pure vitreous samples were prepared according to a modification of the protocol adopted for cytology samples at the Faculty of Medicine, University of Indonesia (FKUI) Integrated Laboratory. After incubation for 10 minutes at room temperature in the dark, the samples were centrifuged for 5 minutes at 1500 rpm. The supernatant was discarded and washed with 2.5 mL of buffer solution. Antibody was added, and the samples were then incubated in the dark at room temperature for 20 minutes. After 20 minutes, excess antibody was washed away with buffer solution. Flow cytometry was performed using a FACSCanto II flow cytometer (Becton Dickinson, San Jose, CA). The results were analyzed using the FACSDiva program.
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Ari Djatikusumo, MD principal investigator
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
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% eyedrops in people with Proliferative Vitreoretinopathy and Rhegmatogenous Retinal Detachment, run by Universitas Indonesia at 1 site in Indonesia.
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 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: finished, as of the sponsor's last update on 9 Sep 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Prostaglandin E2 (PGE2) (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 9 Sep 2025.