Choroidal Neovascular MembraneNCT01361828
Optic Nerve and Retinal Functions With Bevacizumab
An observational study of Choroidal Neovascular Membrane, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes. Read more about this study
- Who is it for?
- Ages 24 to 62 years
- Conditions the study is for
- Choroidal Neovascular Membrane
- What is being tested?
- Electrophysiology
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- 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 24 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.Mean age was 50 years ranging from 24-62 years with 25 females, with 28 AMD and 17 myopic patients.
Who may be able to join
- CNV
Who cannot join
- Previous Intravitreal Injections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).
The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.
Read the detailed description
To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked Potentials (VEP). Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.
- Conditions
- Choroidal Neovascular Membrane
- Being tested
- Electrophysiology
- Keywords
- Bevacizumab, VEP, ERG, Optic nerve and retinal functions following intravitreal bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrophysiologyProcedure or surgery
Visual Evoked Potential and Elctroretinogram
| Study group | Role | What they receive |
|---|---|---|
| Patients with choroidal neovascularization | CNV due to Age-Related Macular Degenerations and Myopia were included. Receives: Procedure: Electrophysiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Evoked Potential and Electroretinogram
VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.
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 posted27 May 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal Neovascular MembraneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Investigators
- Tamer A macky, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361828
- Sponsor's protocol ID
- Beva-ERG-VEP
- Status last verified
- Jan 2010
- First submitted
- 26 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).
- ClinicalTrials.gov ID
- NCT01361828
- Acronym / sponsor ID
- Beva-ERG-VEP
- Conditions
- Choroidal Neovascular Membrane
- Keywords
- Bevacizumab, VEP, ERG, Optic nerve and retinal functions following intravitreal bevacizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 May 2011 (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.
The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.
Detailed description
To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked Potentials (VEP). Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with choroidal neovascularization | – | Procedure: ElectrophysiologyCNV due to Age-Related Macular Degenerations and Myopia were included. |
Who may qualify
- Ages
- 24 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.Mean age was 50 years ranging from 24-62 years with 25 females, with 28 AMD and 17 myopic patients.
Key inclusion criteria (1 listed)
- CNV
Key exclusion criteria (1 listed)
- Previous Intravitreal Injections
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 |
|---|---|---|
| ElectrophysiologyVisual Evoked Potential and Elctroretinogram | Procedure or surgery | Patients with choroidal neovascularization |
Primary outcome
Visual Evoked Potential and Electroretinogram
Time frame: 4 weeks
VEP and ERG baseline and at 1 and 4 weeks post intravitreal injection of bevacizumab.
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 27 May 2011.
- Electrophysiological assessment of retinal function during 6 months of bevacizumab treatment in neovascular age-related macular degeneration.Link provided by the sponsor.
Related trials for Choroidal Neovascular Membrane
Not yet recruiting
Photobiomodulation for Dry Age Related Macula Degeneration
Photobiomodulation, Age-Related Macular Degeneration
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.
Tamer A macky 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?
An observational study of Choroidal Neovascular Membrane, 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 1 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 27 May 2011. 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.
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?
Visual Evoked Potential and Electroretinogram (time frame: 4 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 27 May 2011.