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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051583
First Posted: January 18, 2010
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
AL-Nour Eye Hospital
Kasr El Aini Hospital
Information provided by:
Cairo University
  Purpose
Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma.

Condition Intervention Phase
Neovascular Glaucoma Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avastin as an Adjunct to Diode Laser Cyclophotoablation in the Treatment of Neovascular Glaucoma

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Disappearance of iris neovessels [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Intra ocular pressure [ Time Frame: 4 weeks ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin , diode laser cyclophotcoagulation
Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation
Procedure: 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).
Other Name: bevacizumab
Active Comparator: Diode Laser cyclophotocoagulation
Diode laser cyclophotocoagulation to control intraocular pressure
Procedure: 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).
Other Name: bevacizumab

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 72 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neovascular absolute glaucoma
  • Painful blind eyes

Exclusion Criteria:

  • Neovascular glaucoma with useful vision or potential for useful vision
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051583


Locations
Egypt
Kasr El-Ainy hospital, Cairo university,ophthalmology departement
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
AL-Nour Eye Hospital
Kasr El Aini Hospital
Investigators
Principal Investigator: Mostafa A EL-Helw, M.D. Cairo University
  More Information

Responsible Party: Dr.Mostafa Aly EL-Helw assistant professor, Cairo university, school of medicine, ophthalmology departement. El-Nour Eye hospital
ClinicalTrials.gov Identifier: NCT01051583     History of Changes
Other Study ID Numbers: NVG AV1
First Submitted: January 7, 2010
First Posted: January 18, 2010
Last Update Posted: January 18, 2010
Last Verified: December 2007

Keywords provided by Cairo University:
Neovascular glaucoma
diode laser
cyclophotocoagulation
Avastin

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents