search
Back to results

Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

Primary Purpose

Proliferative Diabetic Retinopathy, Diabetic Macular Edema

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ranibizumab
Sham injection
Pars plana vitrectomy
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring PDR, DME, ranibizumab, vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age≥18 years old;
  2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
  3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion
  4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
  3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
  4. Clinically confirmed intraocular pressure (IOP) >=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye

Sites / Locations

  • Ningbo Eye Hospital
  • Eye & Ent Hospital of Fudan University
  • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ranibizumab

Sham injection

Arm Description

Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy

Sham injection 3~7 days before vitrectomy

Outcomes

Primary Outcome Measures

Early postoperative vitreous haemorrhage
To compare the incidence of the early postoperative vitreous haemorrhage between two arms

Secondary Outcome Measures

Mean Best-corrected visual acuity (BCVA) at Month 3
To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
Mean Best-corrected visual acuity (BCVA) at Month 6
To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.

Full Information

First Posted
July 5, 2020
Last Updated
July 7, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT04464694
Brief Title
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Official Title
Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Detailed Description
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy. Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy. Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Diabetic Macular Edema
Keywords
PDR, DME, ranibizumab, vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy
Arm Title
Sham injection
Arm Type
Sham Comparator
Arm Description
Sham injection 3~7 days before vitrectomy
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Patients will receive single sham injection 3~7 days before vitrectomy.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy
Other Intervention Name(s)
Vitrectomy
Intervention Description
Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
Primary Outcome Measure Information:
Title
Early postoperative vitreous haemorrhage
Description
To compare the incidence of the early postoperative vitreous haemorrhage between two arms
Time Frame
From day 1 to week 4 after the vitrectomy
Secondary Outcome Measure Information:
Title
Mean Best-corrected visual acuity (BCVA) at Month 3
Description
To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
Time Frame
Month 3 after vitrectomy
Title
Mean Best-corrected visual acuity (BCVA) at Month 6
Description
To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
Time Frame
Month 6 after vitrectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥18 years old; Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion Ability to provide written informed consent and comply with study assessments for the full duration of the study. Exclusion Criteria: Pregnancy or lactation; History of stroke, peripheral vascular disease, angina or myocardial infarction within six months Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline; Clinically confirmed intraocular pressure (IOP) >=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiquan Zhao
Phone
13311620396
Email
Zhaopeiquan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiquan Zhao
Organizational Affiliation
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ningbo Eye Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanyong Yi
Phone
13586543802
Email
1067572232@qq.com
Facility Name
Eye & Ent Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
2000831
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Huang
Phone
13818902665
Email
xinhuang66@icloud.com
Facility Name
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
City
Shanghai
ZIP/Postal Code
2000892
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiquan Zhao
Phone
+8613311620396
Email
zhaopeiquan@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19584650
Citation
Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88.
Results Reference
result
PubMed Identifier
21278146
Citation
Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27.
Results Reference
result
PubMed Identifier
28498374
Citation
Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12.
Results Reference
result

Learn more about this trial

Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

We'll reach out to this number within 24 hrs