Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Study Details
Study Description
Brief Summary
To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: intravitreal ranibizumab
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.
Other Names:
Procedure: Trabeculectomy with mitomycinC
All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.
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Outcome Measures
Primary Outcome Measures
- 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
- The safety of intravitreal ranibizumab (IVR) [On the day patient receives IVR]
Blood pressure (mmHg) change
Eligibility Criteria
Criteria
Inclusion Criteria:
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Consecutive patients with neovascular glaucoma
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Age more than 80 year old
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Provide written informed consent
Exclusion Criteria:
- Un-cooperated patients
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Naris Kitnarong | Bangkok | Thailand | 10700 |
Sponsors and Collaborators
- Siriraj Hospital
Investigators
- Principal Investigator: Naris Kitnarong, M.D., Mahidol University
Study Documents (Full-Text)
None provided.More Information
Publications
- Alkawas AA, Shahien EA, Hussein AM. Management of neovascular glaucoma with panretinal photocoagulation, intravitreal bevacizumab, and subsequent trabeculectomy with mitomycin C. J Glaucoma. 2010 Dec;19(9):622-6. doi: 10.1097/IJG.0b013e3181ccb794.
- Kitnarong N, Chindasub P, Metheetrairut A. Surgical outcome of intravitreal bevacizumab and filtration surgery in neovascular glaucoma. Adv Ther. 2008 May;25(5):438-43. doi: 10.1007/s12325-008-0047-5.
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