NCT02647515

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

December 30, 2015

Last Update Submit

January 4, 2016

Conditions

Diabetic RetinopathyGlaucoma, Neovascular

Outcome Measures

Primary Outcomes (2)

  • vitreous hemorrhage

    12 months

  • intraocular pressure

    12 months

Study Arms (1)

ranibizumab

EXPERIMENTAL
Drug: ranibizumab

Interventions

ranibizumabDRUG
ranibizumab

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 6192378BACKGROUND

  • 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.

    PMID: 23893090BACKGROUND

  • 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.

    PMID: 27293875DERIVED

MeSH Terms

Conditions

Diabetic RetinopathyGlaucoma, Neovascular

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlaucomaOcular Hypertension

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 6, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2016

Record last verified: 2013-01

Data Sharing

IPD Sharing
Will share