Clinical trial NCT02857491: Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: perioperative hemorrhage of the surgical eye
timeFrame: 3 month
Secondary outcomes:
measure: size of retinal non-perfusion area assessed by fluorescene angiography
timeFrame: 3 month
measure: macular retinal thickness assessed with optical coherance tomography
timeFrame: 3 month
measure: retinal vessel oxygen saturation measured with a retinal oximeter
timeFrame: 3 months
measure: best-corrected visual acuity
timeFrame: 3 months
Other outcomes:
measure: complications
timeFrame: 3 months
measure: surgical time
timeFrame: 1 day
measure: grade of surgical difficulty
timeFrame: 1 day
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Lin Lu
role: PRINCIPAL_INVESTIGATOR
References: