NCT02857491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

July 27, 2016

Last Update Submit

October 12, 2017

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • perioperative hemorrhage of the surgical eye

    3 month

Secondary Outcomes (4)

  • size of retinal non-perfusion area assessed by fluorescene angiography

    3 month

  • macular retinal thickness assessed with optical coherance tomography

    3 month

  • retinal vessel oxygen saturation measured with a retinal oximeter

    3 months

  • best-corrected visual acuity

    3 months

Other Outcomes (3)

  • complications

    3 months

  • surgical time

    1 day

  • grade of surgical difficulty

    1 day

Study Arms (2)

ranibizumab

EXPERIMENTAL

Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.

Drug: ranibizumabProcedure: pars plana vitrectomy

control

SHAM COMPARATOR

Sham intravitreal injection one week before vitrectomy.

Drug: shamProcedure: pars plana vitrectomy

Interventions

ranibizumabDRUG

intravitreal injection of 0.5 mg ranibizumab before vitrectomy

Also known as: Lucentis
ranibizumab
shamDRUG

sham intravitreal injection before vitrectomy

Also known as: control
control
pars plana vitrectomyPROCEDURE

surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.

Also known as: vitrectomy
controlranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

Ranibizumabsalicylhydroxamic acidVitrectomy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Lin Lu

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Fundus Disease Center

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 5, 2016

Study Start

July 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)