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

Primary Purpose

Neovascular Glaucoma

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Glaucoma focused on measuring Neovascular glaucoma, diode laser, cyclophotocoagulation, Avastin

Eligibility Criteria

14 Years - 72 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neovascular absolute glaucoma
  • Painful blind eyes

Exclusion Criteria:

  • Neovascular glaucoma with useful vision or potential for useful vision

Sites / Locations

  • Kasr El-Ainy hospital, Cairo university,ophthalmology departement

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avastin , diode laser cyclophotcoagulation

Diode Laser cyclophotocoagulation

Arm Description

Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation

Diode laser cyclophotocoagulation to control intraocular pressure

Outcomes

Primary Outcome Measures

Disappearance of iris neovessels

Secondary Outcome Measures

Intra ocular pressure

Full Information

First Posted
January 7, 2010
Last Updated
January 15, 2010
Sponsor
Cairo University
Collaborators
AL-Nour Eye Hospital, Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01051583
Brief Title
Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma
Official Title
Avastin as an Adjunct to Diode Laser Cyclophotoablation in the Treatment of Neovascular Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cairo University
Collaborators
AL-Nour Eye Hospital, Kasr El Aini Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma
Keywords
Neovascular glaucoma, diode laser, cyclophotocoagulation, Avastin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avastin , diode laser cyclophotcoagulation
Arm Type
Experimental
Arm Description
Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation
Arm Title
Diode Laser cyclophotocoagulation
Arm Type
Active Comparator
Arm Description
Diode laser cyclophotocoagulation to control intraocular pressure
Intervention Type
Procedure
Intervention Name(s)
Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin
Other Intervention Name(s)
bevacizumab
Intervention Description
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).
Primary Outcome Measure Information:
Title
Disappearance of iris neovessels
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Intra ocular pressure
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neovascular absolute glaucoma Painful blind eyes Exclusion Criteria: Neovascular glaucoma with useful vision or potential for useful vision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa A EL-Helw, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr El-Ainy hospital, Cairo university,ophthalmology departement
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

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

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