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

Neovascular Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051583
• Other study ID #: NVG AV1
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2010
• Last updated: January 15, 2010
• Start date: January 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2007
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health, Drug Policy and Planning Center
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 72 Years

Eligibility

Inclusion Criteria:

• Neovascular absolute glaucoma

• Painful blind eyes

Exclusion Criteria:

• Neovascular glaucoma with useful vision or potential for useful vision

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma

Intervention

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).

Locations

Country	Name	City	State
Egypt	Kasr El-Ainy hospital, Cairo university,ophthalmology departement	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	AL-Nour Eye Hospital, Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance of iris neovessels		2 weeks	No
Secondary	Intra ocular pressure		4 weeks	Yes