ElectrophysiologyPhase 3NCT00533689
Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD
A Phase 3 study testing Electroretinography (ERG), Visual Evoked Potentials (VEP) in people with Electrophysiology, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Electrophysiology
- What is being tested?
- Electroretinography (ERG), Visual Evoked Potentials (VEP)
- Type of treatment
- Surgery or procedure
- How many people
- 2,008 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jan 2010
- Phase
- Phase 3
- 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 50 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of CNV secondary to AMD
- No other ocular disease
- No history of kerato-refractive surgery
- No epilepsy
- Ability to perform electrophysiologic study
Who cannot join
- Pregnancy
- Minority
- Epilepsy
- History of kerato-refractive surgery
Trial locations and contacts
1 site in 1 country.
Israel1 site
Departent of Ophthalmlogy, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.
This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.
- Conditions
- Electrophysiology
- Being tested
- Electroretinography (ERG), Visual Evoked Potentials (VEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroretinography (ERG), Visual Evoked Potentials (VEP)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2008
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectrophysiologyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Michaella Goldstein, MD, Principal investigator, Tel-Aviv Sourasky Medical CenterAnat Loewenstein, MD, Study director, Tel-Aviv Sourasky Medical CenterIdo Perlman, PhD, Study chair, Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533689
- Sponsor's protocol ID
- TASMC-07-MG-209-CTIL
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Long-Term Effect of Frequent Anti-VEGF Dosing on Retinal Function in Patients With Neovascular AMD
- ClinicalTrials.gov ID
- NCT00533689
- Acronym / sponsor ID
- TASMC-07-MG-209-CTIL
- Conditions
- Electrophysiology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,008 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2008
- Study completion
- Jan 2010 (estimated)
- First posted
- 21 Sep 2007 (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.
THis study aims to determine whether frequent dosing of intravitreal injections of Ranibizumab (Lucentis) or Bevacizumab (Avastin), which act as VEGF inhibitors, has a deleterious effect on the retina, studied by electrophysiologic testing.
This prospective, non-randomized clinical study will include patients assigned to intravitreal injection of Ranibizumab or Bevacizumab due to neovascular AMD. The patients will undergo repeat ophthalmic evaluation and intravitreal injections every 4-6 weeks, as long as will be deemed necessary. Periodic electrophysiologic evaluation including Electroretinogram (ERG), electro-oculogram (EOG) and Visual Evoked Potentials (VEP) tests will be performed every 3 months.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CNV secondary to AMD
- No other ocular disease
- No history of kerato-refractive surgery
- No epilepsy
- Ability to perform electrophysiologic study
Key exclusion criteria (4 listed)
- Pregnancy
- Minority
- Epilepsy
- History of kerato-refractive surgery
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 |
|---|---|---|
| Electroretinography (ERG), Visual Evoked Potentials (VEP) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2007.
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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.
Michaella Goldstein, MD principal investigator
Tel-Aviv Sourasky Medical Center
Anat Loewenstein, MD study director
Tel-Aviv Sourasky Medical Center
Ido Perlman, PhD study chair
Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electroretinography (ERG), Visual Evoked Potentials (VEP) in people with Electrophysiology, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2007. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michaella Goldstein, MD (+972-3-6925773, michgold@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Sep 2007; AzTrials last refreshed its copy on 7 Nov 2026.