Retinal DiseasePhase 3NCT00370851
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
A Phase 3 study testing Avastin (Bevacizumab) in people with Retinal Disease, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Avastin (Bevacizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteIran
- Study dates
- Aug 2006to Jun 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute BRVO with less than three month duration
Who cannot join
- vision less than 20/320 and vison more than 20/50
- duration more than 3 months
- history of glaucoma and diabetic retinopathy
- any media opacity that prevent funduscopy
Trial locations and contacts
1 site in 1 country.
About this study
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE
Read the detailed description
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.
- Conditions
- Retinal Disease
- Being tested
- Avastin (Bevacizumab)
- Keywords
- intravitreal Avastin, BRVO, Macular edema
- Medical subject headings
- Retinal Diseases, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (Bevacizumab)Drug
Intravitreal injection of 125 mg Avastin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intravitreal injection of Avastin Receives: Drug: Avastin (Bevacizumab) |
| 2 | Sham comparator | Not described Receives: Drug: Avastin (Bevacizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: At 12 week
Macular thickness by OCT
Measured: At 12 week
Secondary outcomes (2)
Need for macular photocuagulation
Measured: At 12th week
Incidence of new vessel formation
Measured: At 12th week
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 startAug 2006
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Siamak Moradian, MD, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370851
- Sponsor's protocol ID
- 8532
- Status last verified
- Nov 2009
- First submitted
- 31 Aug 2006
- Last updated
- 25 Nov 2009
- Results posted
- No
Publications
Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.
PubMed 21337043
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00370851
- Acronym / sponsor ID
- 8532
- Conditions
- Retinal Disease
- Keywords
- intravitreal Avastin, BRVO, Macular edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 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.
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE
Detailed description
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Avastin (Bevacizumab)Intravitreal injection of Avastin |
| 2 | Sham comparator | Drug: Avastin (Bevacizumab) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute BRVO with less than three month duration
Key exclusion criteria (4 listed)
- vision less than 20/320 and vison more than 20/50
- duration more than 3 months
- history of glaucoma and diabetic retinopathy
- any media opacity that prevent funduscopy
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 |
|---|---|---|
| Avastin (Bevacizumab)Intravitreal injection of 125 mg Avastin | Drug | 1, 2 |
Primary outcome
Best corrected visual acuity
Time frame: At 12 week
Macular thickness by OCT
Time frame: At 12 week
2 secondary outcomes
Need for macular photocuagulation
Time frame: At 12th week
Incidence of new vessel formation
Time frame: At 12th week
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 25 Nov 2009.
- Derived from this study: PubMed 21337043Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.
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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.
Siamak Moradian, 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 Avastin (Bevacizumab) in people with Retinal Disease, 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 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: finished, as of the sponsor's last update on 25 Nov 2009. 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. Some participants in this study may receive a placebo. 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?
Best corrected visual acuity (time frame: At 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370851, which also lists 1 linked publication.
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 25 Nov 2009.