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

NCT ID: NCT02647515

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Diabetic Retinopathy; Glaucoma, Neovascular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ranibizumab

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

Interventions

ranibizumab

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo University

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xi Shen

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 6192378 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23893090 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27293875 (View on PubMed)

Other Identifiers

XShen

Identifier Type: -

Identifier Source: org_study_id