Diabetic RetinopathyNCT06559488
IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes
A study testing Bevacizumab Injection [Avastin] and Pars Plana Vitrectomy in people with Diabetic Retinopathy and Vitreous Hemorrhage, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Vitreous Hemorrhage
- What is being tested?
- Bevacizumab Injection [Avastin] 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
- 18 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Apr 2018to 31 Mar 2019
- 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 spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.
Who cannot join
- Patients with tractional retinal detachment (ART)
- Patients with severe fibrovascular traction,
- Patients with intravitreal gas or silicone oil tamponade at the end of surgery
- Patients with other eye diseases besides diabetic vitreous hemorrhage
- Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
- Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy
- Patients with inability to attend follow-up examinations for at least 1 month
- Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.
Read the detailed description
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.
- Conditions
- Diabetic Retinopathy, Vitreous Hemorrhage
- Being tested
- Bevacizumab Injection [Avastin], Pars Plana Vitrectomy
- Keywords
- Diabetic vitreous hemorrhage, Intravitreal bevacizumab, Pars plana vitrectomy, Proliferative diabetic retinopathy, Recurrent vitreous hemorrhage
- Medical subject headings
- Diabetic Retinopathy, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Injection [Avastin]Drug
Also called Pars Plana Vitrectomy
Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery.
Pars Plana VitrectomyProcedure or surgery
routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab Intravitreal | Experimental | Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana. Receives: Drug: Bevacizumab Injection [Avastin]; Procedure: Pars Plana Vitrectomy |
| Control | Experimental | Eight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Receives: Procedure: Pars Plana Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Vitreal Hemorrhage Post-Operative
Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes
Measured: Day 1, 7, and 30
Secondary outcomes (1)
Post operative visual Acuity, compared between groups
Visual acuity measured with a Snellen chart was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. Snellen visual acuity of finger counting was categorized as log MAR 2.0, and hand motion as log MAR 3.0
Measured: Day 1, 7, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start2 Apr 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- A parallel group design was employed. Patients requiring vitrectomy for diabetic non-clearing vitreous hemorrhage (VH) were divided into two groups: Intervention Group: Underwent vitrectomy followed by an intravitreal injection of bevacizumab (1.25 mg/0.05 mL). Control Group: Underwent vitrectomy alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- Cicendo Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Mohamad Eko Prayogo, MD, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559488
- Sponsor's protocol ID
- OPHTH-202408.01
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage
- ClinicalTrials.gov ID
- NCT06559488
- Acronym / sponsor ID
- OPHTH-202408.01
- Conditions
- Diabetic Retinopathy, Vitreous Hemorrhage
- Keywords
- Diabetic vitreous hemorrhage, Intravitreal bevacizumab, Pars plana vitrectomy, Proliferative diabetic retinopathy, Recurrent vitreous hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- Cicendo Eye Hospital
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 19 Aug 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.
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.
Detailed description
Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group design was employed. Patients requiring vitrectomy for diabetic non-clearing vitreous hemorrhage (VH) were divided into two groups: Intervention Group: Underwent vitrectomy followed by an intravitreal injection of bevacizumab (1.25 mg/0.05 mL). Control Group: Underwent vitrectomy alone.
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab Intravitreal | Experimental | Drug: Bevacizumab Injection [Avastin], Procedure: Pars Plana VitrectomyTen patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana. |
| Control | Experimental | Procedure: Pars Plana VitrectomyEight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. |
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 spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.
Key exclusion criteria (8 listed)
- Patients with tractional retinal detachment (ART)
- Patients with severe fibrovascular traction,
- Patients with intravitreal gas or silicone oil tamponade at the end of surgery
- Patients with other eye diseases besides diabetic vitreous hemorrhage
- Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery
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 |
|---|---|---|
| Bevacizumab Injection [Avastin]Also: Pars Plana VitrectomyIntravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery. | Drug | Bevacizumab Intravitreal |
| Pars Plana Vitrectomyroutine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients | Procedure or surgery | Bevacizumab Intravitreal, Control |
Primary outcome
Incidence and Severity of Vitreal Hemorrhage Post-Operative
Time frame: Day 1, 7, and 30
Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes
1 secondary outcome
Post operative visual Acuity, compared between groups
Time frame: Day 1, 7, and 30
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 27 Aug 2024.
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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.
Mohamad Eko Prayogo, MD principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bevacizumab Injection [Avastin] and Pars Plana Vitrectomy in people with Diabetic Retinopathy and Vitreous Hemorrhage, run by Universitas Padjadjaran 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 1 inclusion and 8 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 27 Aug 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 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. 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?
Incidence and Severity of Vitreal Hemorrhage Post-Operative (time frame: Day 1, 7, and 30). 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 27 Aug 2024.