NCT01922154

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

August 4, 2013

Last Update Submit

July 12, 2021

Conditions

Glaucoma, Neovascular

Keywords

Angiogenesis inhibitorsNeovascularIntraocular pressureRetinal Vein OcclusionVascular Endothelial Growth Factor

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change of IOP between before trabeculectomy and at last visit

Secondary Outcomes (1)

  • The safety of intravitreal ranibizumab (IVR)

    On the day patient receives IVR

Study Arms (1)

intravitreal ranibizumab

EXPERIMENTAL

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 ranibizumabProcedure: Trabeculectomy with mitomycinC

Interventions

intravitreal ranibizumabDRUG

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.

Also known as: Lucentis; Genentech Inc, San Francisco, CA
intravitreal ranibizumab
Trabeculectomy with mitomycinCPROCEDURE

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

intravitreal ranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Un-cooperated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naris Kitnarong

Bangkok, 10700, Thailand

Location

Related Publications (3)

  • 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.

    PMID: 18425438BACKGROUND

  • 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.

    PMID: 20179624BACKGROUND

  • 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.

    PMID: 18173426RESULT

MeSH Terms

Conditions

Glaucoma, NeovascularRetinal Vein Occlusion

Interventions

RanibizumabTrabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesRetinal DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsFiltering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Naris Kitnarong, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 4, 2013

First Posted

August 14, 2013

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)