Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

NCT ID: NCT01922154

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma, Neovascular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intravitreal ranibizumab

Intervention Type DRUG

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.

Trabeculectomy with mitomycinC

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DRUG

Trabeculectomy with mitomycinC

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

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis; Genentech Inc, San Francisco, CA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Un-cooperated patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Naris Kitnarong

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naris Kitnarong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Naris Kitnarong

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 18425438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20179624 (View on PubMed)

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.

Reference Type RESULT
PMID: 18173426 (View on PubMed)

Other Identifiers

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NK002

Identifier Type: -

Identifier Source: org_study_id

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