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Completed

NCT Number: NCT01922154

Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

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

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Key information

Conditions

Glaucoma, Neovascular Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Glaucoma Ocular Hypertension Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Naris Kitnarong

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Un-cooperated patients

Treatment and study plan

Intravitreal ranibizumab

Drug

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: Lucentis; Genentech Inc, San Francisco, CA

Trabeculectomy with mitomycinC

Procedure

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

Primary outcomes

  1. The change of intraocular pressure (IOP)

    Time frame: 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 outcomes

  1. The safety of intravitreal ranibizumab (IVR)

    Time frame: On the day patient receives IVR

    Blood pressure (mmHg) change

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 14, 2013
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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