Proliferative Diabetic RetinopathyNCT02857491
Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy
A study testing ranibizumab and pars plana vitrectomy in people with Proliferative Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- ranibizumab and pars plana 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to 30 Sep 2017
- 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
- type I or type II diabetes
- there is clear indications for vitrectomy due to proliferative membrane in the vitreoretinal interface, mild hemorrhage, or tractional retinal detachment
- retinal large vessels could be detected within one PD away from the edge of optic disc by OCT
- microcurculation could be detected by FFA in at least one quadrant
- the patient could tolerant FFA examination
Who cannot join
- a history of vitrectomy or scleral bucke in the included eye
- retinal laser photocoagulation treatment within 90 days in the included eye
- anti-VEGF treatment with 90 days in either eye
- there is cocurrent neovascular glaucoma in the included eye
- any reason that might hinde the procedure of vitrectomy, FFA OCT or the observation of ocular fudus
- a history of cere-brovascular accident or heart stroke
- renal failure
- could not attend follow up regularly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravitreal Injection of Ranibizumab Versus Sham Injection Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy: a Single-center, Prospective Double-blinded Randomized Controlled Trial
Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.
Read the detailed description
Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- ranibizumab, sham, pars plana vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
intravitreal injection of 0.5 mg ranibizumab before vitrectomy
shamDrug
Also called control
sham intravitreal injection before vitrectomy
pars plana vitrectomyProcedure or surgery
Also called vitrectomy
surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy. Receives: Drug: ranibizumab; Procedure: pars plana vitrectomy |
| control | Sham comparator | Sham intravitreal injection one week before vitrectomy. Receives: Drug: sham; Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative hemorrhage of the surgical eye
Measured: 3 month
Secondary outcomes (4)
size of retinal non-perfusion area assessed by fluorescene angiography
Measured: 3 month
macular retinal thickness assessed with optical coherance tomography
Measured: 3 month
retinal vessel oxygen saturation measured with a retinal oximeter
Measured: 3 months
best-corrected visual acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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 Sun Yat-sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, Sun Yat-sen University
- Investigators
- Lin Lu, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857491
- Sponsor's protocol ID
- 2014MEKY034
- Status last verified
- Oct 2017
- First submitted
- 27 Jul 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravitreal Injection of Ranibizumab Versus Sham Injection Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy: a Single-center, Prospective Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02857491
- Acronym / sponsor ID
- 2014MEKY034
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.
Detailed description
Eyes responding to panretinal photocoagulation can remain stable for decades, but incomplete responses and relapses can occur in a certain percent of diabetic patients showing as proliferative diabetic retinopathy. At present vitrectomy is the main intervention for those eyes with vitreous hemorrhage, proliferative membrane, and tractional retinal detachment. And the surgical procedure might be complicated because of intraoperative bleeding. And post-operative complications might be also involved. Perioperative use of intraocular anti-VEGF might be associated with less hemorrhage related complications and better visula acuity. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection one week before surgery. The investigators tried to make sure whether pre-operative injection of ranibizuman can reduce reduce intra-operative bleeding, reduce the frequency of using endodiathermy, decrease surgical time, improve microcurculation of retina, and elevte best-corrected visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: ranibizumab, Procedure: pars plana vitrectomyIntravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy. |
| control | Sham comparator | Drug: sham, Procedure: pars plana vitrectomySham intravitreal injection one week before vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- type I or type II diabetes
- there is clear indications for vitrectomy due to proliferative membrane in the vitreoretinal interface, mild hemorrhage, or tractional retinal detachment
- retinal large vessels could be detected within one PD away from the edge of optic disc by OCT
- microcurculation could be detected by FFA in at least one quadrant
- the patient could tolerant FFA examination
Key exclusion criteria (8 listed)
- a history of vitrectomy or scleral bucke in the included eye
- retinal laser photocoagulation treatment within 90 days in the included eye
- anti-VEGF treatment with 90 days in either eye
- there is cocurrent neovascular glaucoma in the included eye
- any reason that might hinde the procedure of vitrectomy, FFA OCT or the observation of ocular fudus
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 |
|---|---|---|
| ranibizumabAlso: Lucentisintravitreal injection of 0.5 mg ranibizumab before vitrectomy | Drug | ranibizumab |
| shamAlso: controlsham intravitreal injection before vitrectomy | Drug | control |
| pars plana vitrectomyAlso: vitrectomysurgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina. | Procedure or surgery | control, ranibizumab |
Primary outcome
perioperative hemorrhage of the surgical eye
Time frame: 3 month
4 secondary outcomes
size of retinal non-perfusion area assessed by fluorescene angiography
Time frame: 3 month
macular retinal thickness assessed with optical coherance tomography
Time frame: 3 month
retinal vessel oxygen saturation measured with a retinal oximeter
Time frame: 3 months
best-corrected visual acuity
Time frame: 3 months
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 16 Oct 2017.
- 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.
Lin Lu principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ranibizumab and pars plana vitrectomy in people with Proliferative Diabetic Retinopathy, run by Sun Yat-sen University 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 5 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 16 Oct 2017. 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. 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.
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?
perioperative hemorrhage of the surgical eye (time frame: 3 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 16 Oct 2017.