Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

July 12, 2021 updated by: Naris Kitnarong, Siriraj Hospital
To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Naris Kitnarong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Un-cooperated patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Lucentis; Genentech Inc, San Francisco, CA
Procedure: Trabeculectomy with mitomycinC
All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change of IOP between before trabeculectomy and at last visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of intravitreal ranibizumab (IVR)
Time Frame: On the day patient receives IVR
Blood pressure (mmHg) change
On the day patient receives IVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

August 4, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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