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

NCT01051583 | Completed Phase 2 DMC

• 1 other identifier: NVG AV1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neovascular Glaucoma

Keywords

Neovascular glaucoma; diode laser; cyclophotocoagulation; Avastin

Outcome Measures

Primary Outcomes (1)

• Disappearance of iris neovessels

  2 weeks

Secondary Outcomes (1)

• Intra ocular pressure

  4 weeks

Study Arms (2)

Avastin , diode laser cyclophotcoagulation

EXPERIMENTAL

Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation

Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin

Diode Laser cyclophotocoagulation

ACTIVE COMPARATOR

Diode laser cyclophotocoagulation to control intraocular pressure

Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin

Interventions

Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin PROCEDURE

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).

Also known as: bevacizumab

Avastin , diode laser cyclophotcoagulation; Diode Laser cyclophotocoagulation

Eligibility Criteria

• Age: 14 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neovascular absolute glaucoma
• Painful blind eyes

You may not qualify if:

• Neovascular glaucoma with useful vision or potential for useful vision

Sponsors & Collaborators

• Cairo University: lead
• AL-Nour Eye Hospital: collaborator
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Kasr El-Ainy hospital, Cairo university,ophthalmology departement

Cairo, Cairo Governorate, 11451, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mostafa A EL-Helw, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 18, 2010
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 18, 2010

Record last verified: 2007-12

Locations

EG (1)