Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Phase 4

Completed

• Conditions: Glaucoma, Neovascular
• Interventions: Drug: intravitreal ranibizumab; Procedure: Trabeculectomy with mitomycinC

• Registration Number: NCT01922154
• Lead Sponsor: Siriraj Hospital

Brief Summary

To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).

Detailed Description

This is a prospective study of 15 consecutive eyes from 14 patients (One patients had NVG in both eyes at presentation.) with NVG presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand between December 2008 and December 2009. Each eye received IVR (0.5 mg/0.05 ml) 1 week before TMC. Trabeculectomy was performed with fornix-based conjunctival flap method.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-08-04
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Consecutive patients with neovascular glaucoma
• Age more than 80 year old
• Provide written informed consent

Exclusion Criteria

• Un-cooperated patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravitreal ranibizumab	intravitreal ranibizumab	Ranibizumab was injected into vitreous cavity in the study eye once (0.5 mg/0.05 ml) at least 1 week before performing trabeculectomy with mitomycin C.
intravitreal ranibizumab	Trabeculectomy with mitomycinC	Ranibizumab was injected into vitreous cavity in the study eye once (0.5 mg/0.05 ml) at least 1 week before performing trabeculectomy with mitomycin C.

Primary Outcome Measures

Name	Time	Method
The change of intraocular pressure (IOP)	Change of IOP between before trabeculectomy and at last visit	The change of intraocular pressure (IOP)between before trabeculectomy with mitomycin C (TMC) and after TMC. We compared this change at several time points such as at 6, 12 months and at last visit. The most important is the change of IOP between before TMC and at last visit as well as the level of IOP at last visit which is at of the longest follow-up time.

Secondary Outcome Measures

Name	Time	Method
The safety of intravitreal ranibizumab (IVR)	On the day patient receives IVR	Blood pressure (mmHg) change

Trial Locations

Locations (1)

Naris Kitnarong; 🇹🇭 Bangkok, Thailand