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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01922154
Other study ID # NK002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2009
Est. completion date December 2012

Study information

Verified date July 2021
Source Siriraj Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Consecutive patients with neovascular glaucoma - Age more than 80 year old - Provide written informed consent Exclusion Criteria: - Un-cooperated patients

Study Design


Related Conditions & MeSH terms


Intervention

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.
Procedure:
Trabeculectomy with mitomycinC
All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.

Locations

Country Name City State
Thailand Naris Kitnarong Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View Citation

Dunavoelgyi R, Zehetmayer M, Simader C, Schmidt-Erfurth U. Rapid improvement of radiation-induced neovascular glaucoma and exudative retinal detachment after a single intravitreal ranibizumab injection. Clin Exp Ophthalmol. 2007 Dec;35(9):878-80. doi: 10. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The safety of intravitreal ranibizumab (IVR) Blood pressure (mmHg) change On the day patient receives IVR
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