Neovascular GlaucomaPhase 2NCT01051583
Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma
A Phase 2 study testing Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin in people with Neovascular Glaucoma, run by Cairo University at 1 site in Egypt.
Trial summary
Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma. Read more about this study
- Who is it for?
- Ages 14 to 72 years
- Conditions the study is for
- Neovascular Glaucoma
- What is being tested?
- Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neovascular absolute glaucoma
- Painful blind eyes
Who cannot join
- Neovascular glaucoma with useful vision or potential for useful vision
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr El-Ainy hospital, Cairo university,ophthalmology departement
Cairo, Cairo Governorate, 11451
About this study
Official title: Avastin as an Adjunct to Diode Laser Cyclophotoablation in the Treatment of Neovascular Glaucoma
Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma.
Read the 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.
- Conditions
- Neovascular Glaucoma
- Being tested
- Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin
- Keywords
- Neovascular glaucoma, diode laser, cyclophotocoagulation, Avastin
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser cyclophotocoagulation enhanced by intravitreal injection of AvastinProcedure or surgery
Also called bevacizumab
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).
| Study group | Role | What they receive |
|---|---|---|
| Avastin , diode laser cyclophotcoagulation | Experimental | Intravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation Receives: Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin |
| Diode Laser cyclophotocoagulation | Active comparator | Diode laser cyclophotocoagulation to control intraocular pressure Receives: Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance of iris neovessels
Measured: 2 weeks
Secondary outcomes (1)
Intra ocular pressure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular GlaucomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- AL-Nour Eye Hospital, Kasr El Aini Hospital
- Investigators
- Mostafa A EL-Helw, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051583
- Sponsor's protocol ID
- NVG AV1
- Status last verified
- Dec 2007
- First submitted
- 7 Jan 2010
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin as an Adjunct to Diode Laser Cyclophotoablation in the Treatment of Neovascular Glaucoma
- ClinicalTrials.gov ID
- NCT01051583
- Acronym / sponsor ID
- NVG AV1
- Conditions
- Neovascular Glaucoma
- Keywords
- Neovascular glaucoma, diode laser, cyclophotocoagulation, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- AL-Nour Eye Hospital, Kasr El Aini Hospital
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the treatment of Neovascular Glaucoma.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin , diode laser cyclophotcoagulation | Experimental | Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of AvastinIntravitreal Avastin injection in conjunction with diode laser cyclophotocoagulation |
| Diode Laser cyclophotocoagulation | Active comparator | Procedure: Diode laser cyclophotocoagulation enhanced by intravitreal injection of AvastinDiode laser cyclophotocoagulation to control intraocular pressure |
Who may qualify
- Ages
- 14 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Neovascular absolute glaucoma
- Painful blind eyes
Key exclusion criteria (1 listed)
- Neovascular glaucoma with useful vision or potential for useful vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser cyclophotocoagulation enhanced by intravitreal injection of AvastinAlso: bevacizumabThe 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). | Procedure or surgery | Avastin , diode laser cyclophotcoagulation, Diode Laser cyclophotocoagulation |
Primary outcome
Disappearance of iris neovessels
Time frame: 2 weeks
1 secondary outcome
Intra ocular pressure
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mostafa A EL-Helw, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin in people with Neovascular Glaucoma, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of iris neovessels (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2010.