Choroidal NeovascularizationPhase 3NCT00370786
Effect of Intravitreal Bevacizumab on Non -Age-Related Macular Degeneration (AMD) Related Choroidal Neovascularization (CNV)
A Phase 3 study testing bevacizumab in people with Choroidal Neovascularization, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization
- What is being tested?
- bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIran
- Study dates
- Nov 2005to Feb 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases with subfoveal or juxtafoveal CNV due to a non-AMD related cause.
Who cannot join
- Evidence of AMD
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc
- Conditions
- Choroidal Neovascularization
- Being tested
- bevacizumab
- Keywords
- Choroidal neovascularization (CNV), Bevacizumab, Non AMD, High myopia, angioid streaks, Ocular histoplasmosis, Idiopathic
- Medical subject headings
- Choroidal Neovascularization, Angioid Streaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Secondary outcomes (2)
central macular thickness
Measured: 6 months
leakage in fluorescein angiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startNov 2005
- Primary completionNov 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamid Ahmadieh, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370786
- Sponsor's protocol ID
- 8543
- Status last verified
- Jul 2008
- First submitted
- 30 Aug 2006
- Last updated
- 11 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Bevacizumab on Non -Age-Related Macular Degeneration (AMD) Related Choroidal Neovascularization (CNV)
- ClinicalTrials.gov ID
- NCT00370786
- Acronym / sponsor ID
- 8543
- Conditions
- Choroidal Neovascularization
- Keywords
- Choroidal neovascularization (CNV), Bevacizumab, Non AMD, High myopia, angioid streaks, Ocular histoplasmosis, Idiopathic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Sep 2006 (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.
To evaluate the effect of bevacizumab for treatment of non-AMD choroidal neovascularization (CNV); eg:angioid streaks, ocular histoplasmosis, high myopia, idiopathic,etc
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cases with subfoveal or juxtafoveal CNV due to a non-AMD related cause.
Key exclusion criteria (1 listed)
- Evidence of AMD
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 |
|---|---|---|
| bevacizumab | Drug | 1 |
Primary outcome
Visual acuity
Time frame: 6 months
2 secondary outcomes
central macular thickness
Time frame: 6 months
leakage in fluorescein angiography
Time frame: 6 months
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 11 Jul 2008.
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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.
Hamid Ahmadieh, MD principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
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 bevacizumab in people with Choroidal Neovascularization, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 11 Jul 2008. 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 Iran. 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?
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 acuity (time frame: 6 months). 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 11 Jul 2008.