Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma
This study has been completed.
Sponsor:
Cairo University
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
| Tracking Information | |||||
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| First Received Date ICMJE | January 7, 2010 | ||||
| Last Updated Date | January 15, 2010 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Disappearance of iris neovessels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01051583 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Intra ocular pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma | ||||
| Official Title ICMJE | Avastin as an Adjunct to Diode Laser Cyclophotoablation in the Treatment of Neovascular Glaucoma | ||||
| Brief Summary | Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neovascular Glaucoma | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 14 Years to 72 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Egypt | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01051583 | ||||
| Other Study ID Numbers ICMJE | NVG AV1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr.Mostafa Aly EL-Helw assistant professor, Cairo university, school of medicine, ophthalmology departement. El-Nour Eye hospital | ||||
| Study Sponsor ICMJE | Cairo University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Cairo University | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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