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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02647515
• Collaborator: Ningbo University (Other)
• Enrollment: 18
• Arm: 1
• Duration (Months): 23

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Glaucoma, Neovascular	Drug: ranibizumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ranibizumab	Drug: ranibizumab

Outcome Measures

Primary Outcome Measures

1. vitreous hemorrhage [12 months]

2. intraocular pressure [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ruijin Hospital
• Ningbo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Xi Shen, chief physician, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT02647515
• Other Study ID Numbers: XShen
• First Posted: Jan 6, 2016
• Last Update Posted: Jan 6, 2016
• Last Verified: Jan 1, 2013

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Glaucoma; Diabetic Retinopathy; Glaucoma, Neovascular; Ranibizumab

Study Results

No Results Posted as of Jan 6, 2016