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Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma

Primary Purpose

Diabetic Retinopathy, Glaucoma, Neovascular

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

ranibizumab

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

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

Inclusion Criteria:

age≥18 years
PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions
NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle)

Exclusion Criteria:

intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy
previous intravitreal injection of ranibizumab or bevacizumab in either eye
previous intravitreal corticosteroids injection in either eye
pregnancy or current oral contraceptive intake
usage of clopidogrel bisulfate or coumadin
uncontrolled hypertension and cardiac disease
uncontrolled renal or liver disease

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

vitreous hemorrhage

intraocular pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT02647515

First Posted

December 30, 2015

Last Updated

January 4, 2016

Sponsor

Ruijin Hospital

Collaborators

Ningbo University

1. Study Identification

Unique Protocol Identification Number

NCT02647515

Brief Title

Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Ningbo University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy, Glaucoma, Neovascular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ranibizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Primary Outcome Measure Information:

Title

vitreous hemorrhage

Time Frame

12 months

Title

intraocular pressure

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age≥18 years PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle) Exclusion Criteria: intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy previous intravitreal injection of ranibizumab or bevacizumab in either eye previous intravitreal corticosteroids injection in either eye pregnancy or current oral contraceptive intake usage of clopidogrel bisulfate or coumadin uncontrolled hypertension and cardiac disease uncontrolled renal or liver disease

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

6192378

Citation

Schachat AP, Oyakawa RT, Michels RG, Rice TA. Complications of vitreous surgery for diabetic retinopathy. II. Postoperative complications. Ophthalmology. 1983 May;90(5):522-30. doi: 10.1016/s0161-6420(83)34540-1.

Results Reference

background

PubMed Identifier

23893090

Citation

Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.

Results Reference

background

PubMed Identifier

27293875

Citation

Shen X, Chen Y, Wang Y, Yang L, Zhong Y. Intravitreal Ranibizumab Injection as an Adjuvant in the Treatment of Neovascular Glaucoma Accompanied by Vitreous Hemorrhage after Diabetic Vitrectomy. J Ophthalmol. 2016;2016:4108490. doi: 10.1155/2016/4108490. Epub 2016 May 16.

Results Reference

derived

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Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma

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