EndophthalmitisNCT04192994
Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
A study testing Intravitreal Antibiotic Injection and Pars Plana Vitrectomy in people with Endophthalmitis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Intravitreal Antibiotic Injection and Pars Plana Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 1 Dec 2023
- 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
- Patients with acute endophthalmitis with a history of ocular surgical procedures and a follow-up time of less than 6 weeks will be included.
Who cannot join
- Patients with endophthalmitis lasting more than 6 weeks and no history of eye surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, 04023-062
About this study
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy
Read the detailed description
Endophthalmitis, a severe inflammatory ocular condition with profound visual impairment that can lead to irreversible visual loss, requires immediate treatment.
The only multicenter randomized trial of different forms of acute endophthalmitis treatment was the Endophthalmitis Vitrectomy Study. The study concluded that intravitreal antibiotic injection improves visual prognosis, and pars plana vitrectomy (PPV) improves the final visual acuity (VA) when performed in patients with light perception or worse VA.
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy.
Primary Endpoint: The final VA, ocular anatomy, retinal layer anatomy, and ERG response in the intravitreal injection group will be compared with the PPV group.
Secondary Endpoint: The final VA, eyeball anatomy, retinal layer anatomy, and ERG response in the group that underwent PPV will be compared with and without oral moxifloxacin therapy.
- Conditions
- Endophthalmitis
- Being tested
- Intravitreal Antibiotic Injection, Pars Plana Vitrectomy
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Antibiotic InjectionDrug
Also called Tap Injection
Intravitreal Antibiotic Injection
Pars Plana VitrectomyProcedure or surgery
Also called PPV
Pars Plana Vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Antibiotic injection | Active comparator | A total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected with a 30-gauge needle into the vitreous cavity of the affected eyes in the randomized group, as soon as the diagnosis is confirmed. Receives: Procedure: Pars Plana Vitrectomy |
| Group 2: Pars Plana Vitrectomy | Active comparator | Randomized patients will undergo PPV. Briefly, a blepharostat will be placed followed by instillation of a drop of 5% iodine-povidone over the eye. Under a surgical microscope, three 23-gauge or 25-gauge sclerotomies will be performed. Vitreous core vitrectomy will be performed, and a fluid-gas exchange with balanced saline solution (BSS) or 5,000 grams of silicone oil as a vitreous substitute. At the end of surgery, all sclerotomies will be sutured with Vicryl 7.0 and a total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected into the vitreous cavity. As soon as the diagnosis is confirmed. Receives: Drug: Intravitreal Antibiotic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Correct Visual Acuity
The Final Visual acuity will be measured after 1 year
Measured: 1 year
Ocular Anatomy
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Measured: 1 year
Electroretinography Response (ERG Response)
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Dec 2023
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 EndophthalmitisStudies 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
- Model description
- Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin. Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Vinicius Campos Bergamo, Nilva Simeren Bueno de Moraes, Luis Filipe Nakayama, Natasha Ferreira Santos da Cruz, Murilo Ubukata Polizelli
- Responsible party
- Principal investigator, Mauricio Maia, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192994
- Sponsor's protocol ID
- END_2019
- Status last verified
- May 2024
- First submitted
- 15 Nov 2019
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergamo VC, Nakayama LF, de Moraes NSB, Tavares IM, De Queiroz Campos MS, Hofling-Lima AL, Maia M. Postoperative endophthalmitis treatment with antibiotics associated or not with pars plana vitrectomy: a randomized clinical trial. Int J Retina Vitreous. 2025 Feb 18;11(1):18. doi: 10.1186/s40942-025-00640-1.
PubMed 39966901
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
- ClinicalTrials.gov ID
- NCT04192994
- Acronym / sponsor ID
- END_2019
- Conditions
- Endophthalmitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Vinicius Campos Bergamo, Nilva Simeren Bueno de Moraes, Luis Filipe Nakayama, Natasha Ferreira Santos da Cruz, Murilo Ubukata Polizelli
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 10 Dec 2019 (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.
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy
Detailed description
Endophthalmitis, a severe inflammatory ocular condition with profound visual impairment that can lead to irreversible visual loss, requires immediate treatment.
The only multicenter randomized trial of different forms of acute endophthalmitis treatment was the Endophthalmitis Vitrectomy Study. The study concluded that intravitreal antibiotic injection improves visual prognosis, and pars plana vitrectomy (PPV) improves the final visual acuity (VA) when performed in patients with light perception or worse VA.
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy.
Primary Endpoint: The final VA, ocular anatomy, retinal layer anatomy, and ERG response in the intravitreal injection group will be compared with the PPV group.
Secondary Endpoint: The final VA, eyeball anatomy, retinal layer anatomy, and ERG response in the group that underwent PPV will be compared with and without oral moxifloxacin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin. Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Antibiotic injection | Active comparator | Procedure: Pars Plana VitrectomyA total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected with a 30-gauge needle into the vitreous cavity of the affected eyes in the randomized group, as soon as the diagnosis is confirmed. |
| Group 2: Pars Plana Vitrectomy | Active comparator | Drug: Intravitreal Antibiotic InjectionRandomized patients will undergo PPV. Briefly, a blepharostat will be placed followed by instillation of a drop of 5% iodine-povidone over the eye. Under a surgical microscope, three 23-gauge or 25-gauge sclerotomies will be performed. Vitreous core vitrectomy will be performed, and a fluid-gas exchange with balanced saline solution (BSS) or 5,000 grams of silicone oil as a vitreous substitute. At the end of surgery, all sclerotomies will be sutured with Vicryl 7.0 and a total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected into the vitreous cavity. As soon as the diagnosis is confirmed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acute endophthalmitis with a history of ocular surgical procedures and a follow-up time of less than 6 weeks will be included.
Key exclusion criteria (1 listed)
- Patients with endophthalmitis lasting more than 6 weeks and no history of eye surgery will be excluded.
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 |
|---|---|---|
| Intravitreal Antibiotic InjectionAlso: Tap InjectionIntravitreal Antibiotic Injection | Drug | Group 2: Pars Plana Vitrectomy |
| Pars Plana VitrectomyAlso: PPVPars Plana Vitrectomy | Procedure or surgery | Group 1: Antibiotic injection |
Primary outcome
Best Correct Visual Acuity
Time frame: 1 year
The Final Visual acuity will be measured after 1 year
Ocular Anatomy
Time frame: 1 year
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Electroretinography Response (ERG Response)
Time frame: 1 year
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
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 24 May 2024.
- Derived from this study: PubMed 39966901Bergamo VC, Nakayama LF, de Moraes NSB, Tavares IM, De Queiroz Campos MS, Hofling-Lima AL, Maia M. Postoperative endophthalmitis treatment with antibiotics associated or not with pars plana vitrectomy: a randomized clinical trial. Int J Retina Vitreous. 2025 Feb 18;11(1):18. doi: 10.1186/s40942-025-00640-1.
- Individual participant dataSharing planned: No
Related trials for Endophthalmitis
Not yet recruiting
Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis
Endophthalmitis, Infectious Endophthalmitis
RecruitingObservational study
Nanopore Sequencing in Ophthalmology
Endophthalmitis
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingPhase 1
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
Ocular Inflammation, Crystalline Lens; Chalcosis
Not yet recruitingPhase 2/3
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
Endophthalmitis
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 study testing Intravitreal Antibiotic Injection and Pars Plana Vitrectomy in people with Endophthalmitis, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 24 May 2024. 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 Brazil. 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?
Best Correct Visual Acuity (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT04192994, 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 24 May 2024.