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

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647515
• Other study ID #: XShen
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2015
• Last updated: January 4, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Glaucoma
• Glaucoma, Neovascular

Intervention

Drug:
• ranibizumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Ningbo University

References & Publications (2)

Lüke J, Nassar K, Lüke 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitreous hemorrhage		12 months
Primary	intraocular pressure		12 months