Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

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

Detailed Description
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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.

Official Title
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Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Conditions
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Glaucoma, Neovascular

Intervention / Treatment
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* Drug: intravitreal ranibizumab
* Procedure: Trabeculectomy with mitomycinC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients with neovascular glaucoma Age more than 80 year old Provide written informed consent Exclusion Criteria: Un-cooperated patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravitreal ranibizumab<br>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. | Drug: intravitreal ranibizumab<br>* The patients received IVR (0.5 mg in 0.05 ml) injection through the pars plana in the operating room. A fornix-based conjunctival flap technique trabeculectomy with intraoperative mitomycin C was performed within 2 weeks after IVR.<br>* Other names: Lucentis; Genentech Inc, San Francisco, CA;Procedure: Trabeculectomy with mitomycinC<br>* All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of intraocular pressure (IOP) | 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. | Change of IOP between before trabeculectomy and at last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of intravitreal ranibizumab (IVR) | Blood pressure (mmHg) change | On the day patient receives IVR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor