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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01051583
Other study ID # NVG AV1
Secondary ID
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


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
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