COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01922154
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : August 14, 2013
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.

Layout table for study information
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT01922154

Layout table for location information
Naris Kitnarong
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Layout table for investigator information
Principal Investigator: Naris Kitnarong, M.D. Mahidol University
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Naris Kitnarong, Associate professor, Siriraj Hospital 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
Intraocular pressure
Retinal Vein Occlusion
Vascular Endothelial Growth Factor
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents