Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma

NCT ID: NCT01051583

Last Updated: 2010-01-18

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

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-04-30

Brief Summary

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Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma.

Detailed Description

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Design: Prospective, comparative interventional case series. Method: Patients were randomly assigned into Group A which were treated with Diode laser cyclophotocoagulation alone, whereas group B received intravitreal Avastin (One milligram = 0.04mL of 25 mg/mL) in conjunction with the Diode Laser. The preoperative data included etiology, mean age; follow up period, and a full ophthalmological examination with emphasis on mean IOP, iris neovascularization, pain and corneal edema.

Conditions

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Neovascular Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avastin , diode laser cyclophotcoagulation

Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation

Group Type EXPERIMENTAL

Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin

Intervention Type PROCEDURE

The operative procedure involved retro-bulbar anesthesia, draping the patient in an aseptic manner, introduction of an eye speculum, 30 laser shots over 270 degrees of the circumference of the limbus. For our study we used the Iris Diode laser machine, the G-probe and we adjusted the settings for 2500 millisecond duration and the 3000 milli-joule and reduced the power progressively until just below the energy level that produced a pop.then after applying the laser, we performed a paracentesis with a 27 gauge needle to soften the globe, followed by intravitreal injection of the Avastin from a site 3.5 millimeter posterior to the limbus. The dose we administered was one milligram of bevacizumab (0.04 mL of 25 mg/mL).

Diode Laser cyclophotocoagulation

Diode laser cyclophotocoagulation to control intraocular pressure

Group Type ACTIVE_COMPARATOR

Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin

Intervention Type PROCEDURE

The operative procedure involved retro-bulbar anesthesia, draping the patient in an aseptic manner, introduction of an eye speculum, 30 laser shots over 270 degrees of the circumference of the limbus. For our study we used the Iris Diode laser machine, the G-probe and we adjusted the settings for 2500 millisecond duration and the 3000 milli-joule and reduced the power progressively until just below the energy level that produced a pop.then after applying the laser, we performed a paracentesis with a 27 gauge needle to soften the globe, followed by intravitreal injection of the Avastin from a site 3.5 millimeter posterior to the limbus. The dose we administered was one milligram of bevacizumab (0.04 mL of 25 mg/mL).

Interventions

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Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin

The operative procedure involved retro-bulbar anesthesia, draping the patient in an aseptic manner, introduction of an eye speculum, 30 laser shots over 270 degrees of the circumference of the limbus. For our study we used the Iris Diode laser machine, the G-probe and we adjusted the settings for 2500 millisecond duration and the 3000 milli-joule and reduced the power progressively until just below the energy level that produced a pop.then after applying the laser, we performed a paracentesis with a 27 gauge needle to soften the globe, followed by intravitreal injection of the Avastin from a site 3.5 millimeter posterior to the limbus. The dose we administered was one milligram of bevacizumab (0.04 mL of 25 mg/mL).

Intervention Type PROCEDURE

Other Intervention Names

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bevacizumab

Eligibility Criteria

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Inclusion Criteria

* Neovascular absolute glaucoma
* Painful blind eyes

Exclusion Criteria

* Neovascular glaucoma with useful vision or potential for useful vision
Minimum Eligible Age

14 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AL-Nour Eye Hospital

OTHER

Sponsor Role collaborator

Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Cairo university, school of medicine, ophthalmology departement. El-Nour Eye hospital

Principal Investigators

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Mostafa A EL-Helw, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr El-Ainy hospital, Cairo university,ophthalmology departement

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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NVG AV1

Identifier Type: -

Identifier Source: org_study_id

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