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Completed

NCT Number: NCT02647515

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

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glaucoma Glaucoma, Neovascular Ocular Hypertension Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Primary outcomes

  1. vitreous hemorrhage

    Time frame: 12 months

  2. intraocular pressure

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Ningbo University

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2016
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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