Proliferative Diabetic RetinopathyPhase 4NCT01854593
Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
A Phase 4 study testing Bevacizumab and Vitrectomy in people with Proliferative Diabetic Retinopathy and Diabetic Traction Retinal Detachment, run by Nihon University at 1 site in Japan.
Trial summary
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Diabetic Traction Retinal Detachment, Vitreous Hemorrhage
- What is being tested?
- Bevacizumab and Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteJapan
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Who cannot join
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
Read the detailed description
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
- Conditions
- Proliferative Diabetic Retinopathy, Diabetic Traction Retinal Detachment, Vitreous Hemorrhage
- Being tested
- Bevacizumab, Vitrectomy, Sham injection
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
VitrectomyProcedure or surgery
vitrectomy of 25 gauge system.
Sham injectionDevice
Sham injection one day before vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab injection and vitrectomy | Active comparator | 0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy. Receives: Drug: Bevacizumab; Procedure: Vitrectomy |
| Sham injection and vitrectomy | Sham comparator | Sham injection one day before vitrectomy. Receives: Procedure: Vitrectomy; Device: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
Measured: 1 month
Secondary outcomes (12)
Intra Operative Hemorrhage
Calculate the number of coagulators for the intra operative hemorrhage.
Measured: End of the surgery.
Postoperative Vitreous Hemorrhage.
Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
Measured: 1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
Measured: Start of surgery.
Endolaser Photocoagulation
Number of intraoperative endolaser photocoagulation.
Measured: End of surgery.
Iatrogenic Retinal Tears
The number of participants who had intraoperative iatrogenic retinal tears.
Measured: End of surgery.
Surgical Time
Measured: End of surgery.
Postoperative Best Corrected Visual Acuity
Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.
The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.
Measured: 1 mouth after surgery.
Best Corrected Visual Acuity Change
Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.
The higher values represent a worse outcome.
Measured: 1 month
Postoperative Neovascular Glaucoma
The number of participants with progressive or persistent neovascular glaucoma after surgery.
Measured: Within 1 month after the surgery.
Elevated Intraocular Pressure
The number of participants with elevated intraocular pressure after surgery.
Measured: Within 1 month after the surgery.
Gas Tamponade
The number of participants with gas tamponade at the end of the surgery.
Measured: End of surgery.
Silicon Oil Tamponade
The number of participants with silicon oil tamponade at the end of the surgery.
Measured: End of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Proliferative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayumu Manabe, Nihon University
- Investigators
- Ayumu Manabe, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854593
- Sponsor's protocol ID
- CCT-NAPN-23170
- Status last verified
- Jun 2014
- First submitted
- 13 May 2013
- Last updated
- 14 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01854593
- Acronym / sponsor ID
- CCT-NAPN-23170
- Conditions
- Proliferative Diabetic Retinopathy, Diabetic Traction Retinal Detachment, Vitreous Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
Detailed description
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab injection and vitrectomy | Active comparator | Drug: Bevacizumab, Procedure: Vitrectomy0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy. |
| Sham injection and vitrectomy | Sham comparator | Procedure: Vitrectomy, Device: Sham injectionSham injection one day before vitrectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Key exclusion criteria (1 listed)
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
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 |
|---|---|---|
| BevacizumabAlso: Avastin0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation) | Drug | Bevacizumab injection and vitrectomy |
| Vitrectomyvitrectomy of 25 gauge system. | Procedure or surgery | Bevacizumab injection and vitrectomy, Sham injection and vitrectomy |
| Sham injectionSham injection one day before vitrectomy | Device | Sham injection and vitrectomy |
Primary outcome
Reoperation
Time frame: 1 month
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
12 secondary outcomes
Intra Operative Hemorrhage
Time frame: End of the surgery.
Postoperative Vitreous Hemorrhage.
Time frame: 1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
Time frame: Start of surgery.
Endolaser Photocoagulation
Time frame: End of surgery.
Iatrogenic Retinal Tears
Time frame: End of surgery.
Surgical Time
Time frame: End of surgery.
Postoperative Best Corrected Visual Acuity
Time frame: 1 mouth after surgery.
Best Corrected Visual Acuity Change
Time frame: 1 month
Postoperative Neovascular Glaucoma
Time frame: Within 1 month after the surgery.
Elevated Intraocular Pressure
Time frame: Within 1 month after the surgery.
Gas Tamponade
Time frame: End of surgery.
Silicon Oil Tamponade
Time frame: End of surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ayumu Manabe study chair
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 Bevacizumab and Vitrectomy in people with Proliferative Diabetic Retinopathy and Diabetic Traction Retinal Detachment, run by Nihon University at 1 site in Japan.
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 2 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 14 Jul 2014. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reoperation (time frame: 1 month). 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 14 Jul 2014.