Proliferative Diabetic RetinopathyNCT05478967
The Effect of IVA for Preventing Postvitrectomy Hemorrhage in PDR
A study testing IVA injection before vitrectomy in people with Proliferative Diabetic Retinopathy, run by Peking University People's Hospital at 1 site in China.
Trial summary
Aflibercept, a recombinant fusion antibody that binds to all subtypes of VEGF and PlGF, has been shown to induce effective regression of retinal neovascularization secondary to PDR but there had been lack of a well-structured prospective study about adjunctive use of intravitreal injection of Aflibercept (IVA) to… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- IVA injection before vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2019to 20 Feb 2021
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- age between 35 and 65
- PDR who underwent primary pars plana vitrectomy for VH.
Who cannot join
- eyes with retinal tear
- eyes with iris or anterior angle neovascularization
- eyes with intraoperative use of silicone oil
- eyes with choroidal or retinal disease other than PDR or any inflammation condition
- eyes underwent any previous vitrectomy or scleral buckle surgery
- eyes received intraocular TA injection within 90 days before screening
Show all 12Show fewer
- eyes received intraocular anti VEGF treatment within 60 days before screening or contralateral eyes received intraocular anti VEGF treatment during follow-up
- patients who had taken aspirin orally within 7 days before screening
- patient has coagulation mechanism disorder or other medicine for anticoagulant treatment
- cerebrovascular accident and / or myocardial infarction occurred within 180 days before screening
- patients with uncontrolled blood pressure (sitting position > 160 / 100 mmHg)
- patients with liver or kidney dysfunction or any severe systemic disease.
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
About this study
Official title: The Effect of Adjunctive Intravitreal Aflibercept for Preventing Postvitrectomy Hemorrhage in Proliferative Diabetic Retinopathy
Aflibercept, a recombinant fusion antibody that binds to all subtypes of VEGF and PlGF, has been shown to induce effective regression of retinal neovascularization secondary to PDR but there had been lack of a well-structured prospective study about adjunctive use of intravitreal injection of Aflibercept (IVA) to reduce postoperative VH in PPV for PDR. In this study, we aim to assess the effect of preoperative IVA on the incidence of postoperative VH after PPV for PDR.
Read the detailed description
The enrolled eyes were randomly assigned according to the Central Randomization System with a ratio of 1∶1 to IVA group and control group. Patients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery); patients in control group did not receive IVA injection before vitrectomy. The preoperative IVA injection was performed following a standard protocol. All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge trocar and cannula system under local or anesthesia. Procedures such as fibrovascular membrane dissection, endodiathermy, or endolaser photocoagulation were performed with 25-gauge instruments as required. Intraoperative bleeding was controlled by either endodiathermy or increasing the irrigation pressure. Patients were examined 1 week, 1 month, 2 months, and 3 months after surgery if there were no postoperative events. If postoperative complications, including VH, occurred, patients were instructed to visit the clinic regardless of the visit schedule. At each visit, any events involving the study eye between the visit schedules were recorded accordingly. At each postoperative visit, slit-lamp biomicroscope, indirect ophthalmoscopy, and fundus photographs were performed. The primary outcome of this study was incidence of VH after vitrectomy.
Postoperative VH was defined as a new episode of VH of grade 1 or above occurring later than 3 days after primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system. Incidence of VH at week 1, month 1, month 2 and month 3 were recorded. In the case of gas-injected eye, complications were assessed in the region without the gas bubble.
Preoperative, intraoperative, and postoperative data were collected for each patient. Preoperative data included age; sex; duration and status of diabetes mellitus (HbA1C); other systemic diseases such as hypertension and renal function (serum creatinine); and ophthalmic parameters including best-corrected visual acuity (BCVA), intraocular pressure (IOP), lens status, previous pan-retinal photocoagulation (PRP), and indication for surgery. Intraoperative data included phacoemulsification and intraocular lens (IOL) procedures, SF6 or air tamponade, and the presence of fibrovascular proliferation and tractional retinal detachment. Postoperative data included BCVA at each visit and number of episodes of complications.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- IVA injection before vitrectomy
- Keywords
- Proliferative diabetic retinopathy, vitrectomy, Aflibercept, intravitreal injection, postvitrectomy hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVA injection before vitrectomyProcedure or surgery
Patients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery)
| Study group | Role | What they receive |
|---|---|---|
| IVA group | Experimental | Received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery) Receives: Procedure: IVA injection before vitrectomy |
| control group | No intervention | Did not receive IVA injection before vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of VH
Postoperative VH was defined as a new episode of VH of grade 1 or above occurring later than 3 days after primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system.
Measured: one month after vitrectomy
Secondary outcomes (1)
Changes of BCVA
Changes of BCVA （LogMAR）from baseline at 1 week, 1 month, 2 months and 3 months after vitrectomy
Measured: 1 week, 1 month, 2 months and 3 months after vitrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start8 Aug 2019
- Primary completion20 Jan 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanghai 10th People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Nanchang University, Nanjing Medical University, Xiamen University
- Responsible party
- Principal investigator, Jinfeng Qu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478967
- Sponsor's protocol ID
- IVAPDR
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- 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 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjunctive Intravitreal Aflibercept for Preventing Postvitrectomy Hemorrhage in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05478967
- Acronym / sponsor ID
- IVAPDR
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative diabetic retinopathy, vitrectomy, Aflibercept, intravitreal injection, postvitrectomy hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanghai 10th People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Nanchang University, Nanjing Medical University, Xiamen University
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 28 Jul 2022 (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.
Aflibercept, a recombinant fusion antibody that binds to all subtypes of VEGF and PlGF, has been shown to induce effective regression of retinal neovascularization secondary to PDR but there had been lack of a well-structured prospective study about adjunctive use of intravitreal injection of Aflibercept (IVA) to reduce postoperative VH in PPV for PDR. In this study, we aim to assess the effect of preoperative IVA on the incidence of postoperative VH after PPV for PDR.
Detailed description
The enrolled eyes were randomly assigned according to the Central Randomization System with a ratio of 1∶1 to IVA group and control group. Patients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery); patients in control group did not receive IVA injection before vitrectomy. The preoperative IVA injection was performed following a standard protocol. All patients underwent 25-gauge transconjunctival sutureless vitrectomy using the 25-gauge trocar and cannula system under local or anesthesia. Procedures such as fibrovascular membrane dissection, endodiathermy, or endolaser photocoagulation were performed with 25-gauge instruments as required. Intraoperative bleeding was controlled by either endodiathermy or increasing the irrigation pressure. Patients were examined 1 week, 1 month, 2 months, and 3 months after surgery if there were no postoperative events. If postoperative complications, including VH, occurred, patients were instructed to visit the clinic regardless of the visit schedule. At each visit, any events involving the study eye between the visit schedules were recorded accordingly. At each postoperative visit, slit-lamp biomicroscope, indirect ophthalmoscopy, and fundus photographs were performed. The primary outcome of this study was incidence of VH after vitrectomy.
Postoperative VH was defined as a new episode of VH of grade 1 or above occurring later than 3 days after primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system. Incidence of VH at week 1, month 1, month 2 and month 3 were recorded. In the case of gas-injected eye, complications were assessed in the region without the gas bubble.
Preoperative, intraoperative, and postoperative data were collected for each patient. Preoperative data included age; sex; duration and status of diabetes mellitus (HbA1C); other systemic diseases such as hypertension and renal function (serum creatinine); and ophthalmic parameters including best-corrected visual acuity (BCVA), intraocular pressure (IOP), lens status, previous pan-retinal photocoagulation (PRP), and indication for surgery. Intraoperative data included phacoemulsification and intraocular lens (IOL) procedures, SF6 or air tamponade, and the presence of fibrovascular proliferation and tractional retinal detachment. Postoperative data included BCVA at each visit and number of episodes of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVA group | Experimental | Procedure: IVA injection before vitrectomyReceived an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery) |
| control group | No intervention | –Did not receive IVA injection before vitrectomy |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- age between 35 and 65
- PDR who underwent primary pars plana vitrectomy for VH.
Key exclusion criteria (12 listed)
- eyes with retinal tear
- eyes with iris or anterior angle neovascularization
- eyes with intraoperative use of silicone oil
- eyes with choroidal or retinal disease other than PDR or any inflammation condition
- eyes underwent any previous vitrectomy or scleral buckle 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 |
|---|---|---|
| IVA injection before vitrectomyPatients in IVA group received an IVA (0.5 mg/0.05 ml) injection before surgery (1 to 5 days before surgery) | Procedure or surgery | IVA group |
Primary outcome
Incidence of VH
Time frame: one month after vitrectomy
Postoperative VH was defined as a new episode of VH of grade 1 or above occurring later than 3 days after primary surgery and was evaluated according to the Diabetic Retinopathy Vitrectomy Study grading system.
1 secondary outcome
Changes of BCVA
Time frame: 1 week, 1 month, 2 months and 3 months after vitrectomy
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 28 Jul 2022.
- 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.
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 IVA injection before vitrectomy in people with Proliferative Diabetic Retinopathy, run by Peking University People's Hospital 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 3 inclusion and 12 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 28 Jul 2022. 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?
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 of VH (time frame: one month after vitrectomy). 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 28 Jul 2022.