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Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

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ClinicalTrials.gov Identifier: NCT01922154
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Naris Kitnarong, 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).

Condition or disease Intervention/treatment Phase
Glaucoma, Neovascular Drug: intravitreal ranibizumab 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Study Start Date : February 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Ranibizumab

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 Name: Lucentis; Genentech Inc, San Francisco, CA




Primary Outcome Measures :
  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 Outcome Measures :
  1. The safety of intravitreal ranibizumab (IVR) [ Time Frame: immediately after IVR ]
    Blood pressure (mmHg) change



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Un-cooperated patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922154


Locations
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Thailand
Naris Kitnarong
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Investigators
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Principal Investigator: Naris Kitnarong, M.D. Mahidol University
Publications of Results:
Other Publications:
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Responsible Party: Naris Kitnarong, Associate professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01922154    
Other Study ID Numbers: NK002
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013
Keywords provided by Naris Kitnarong, Siriraj Hospital:
Angiogenesis inhibitors
Neovascular
Intraocular pressure
Retinal Vein Occlusion
Vascular Endothelial Growth Factor
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents