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

This study has been completed.
Sponsor:
Collaborators:
El-Nour eye hospital
Kasr El-Ainy Eye hospital
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01051583
First received: January 7, 2010
Last updated: January 15, 2010
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Disappearance of iris neovessels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra ocular pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   14 Years to 72 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051583

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

No publications provided

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
Study First Received: January 7, 2010
Last Updated: January 15, 2010
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013