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Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

Primary Purpose

Glaucoma, Neovascular

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
intravitreal ranibizumab
Trabeculectomy with mitomycinC
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Neovascular focused on measuring Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Un-cooperated patients

Sites / Locations

  • Naris Kitnarong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intravitreal ranibizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The safety of intravitreal ranibizumab (IVR)
Blood pressure (mmHg) change

Full Information

First Posted
August 4, 2013
Last Updated
July 12, 2021
Sponsor
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01922154
Brief Title
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Official Title
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Neovascular
Keywords
Angiogenesis inhibitors, Neovascular, Intraocular pressure, Retinal Vein Occlusion, Vascular Endothelial Growth Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intravitreal ranibizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
intravitreal ranibizumab
Other Intervention Name(s)
Lucentis; Genentech Inc, San Francisco, CA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy with mitomycinC
Intervention Description
All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.
Primary Outcome Measure Information:
Title
The change of intraocular pressure (IOP)
Description
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.
Time Frame
Change of IOP between before trabeculectomy and at last visit
Secondary Outcome Measure Information:
Title
The safety of intravitreal ranibizumab (IVR)
Description
Blood pressure (mmHg) change
Time Frame
On the day patient receives IVR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients with neovascular glaucoma Age more than 80 year old Provide written informed consent Exclusion Criteria: Un-cooperated patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naris Kitnarong, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naris Kitnarong
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18425438
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.
Results Reference
background
PubMed Identifier
20179624
Citation
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.
Results Reference
background
PubMed Identifier
18173426
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: 10.1111/j.1442-9071.2007.01632.x.
Results Reference
result

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Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

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