Central Retinal Vein OcclusionPhase 3NCT00906685
Bevacizumab for Central Retinal Vein Occlusion Study
A Phase 3 study testing bevacizumab in people with Central Retinal Vein Occlusion, run by Anders Kvanta at 1 site in Sweden.
Trial summary
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Sep 2011
- 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
- CRVO with duration < 6 months
- Visual acuity of 20/800 to 20/50
Who cannot join
- CRVO with duration of > 6 months
- previous treatment with anti-angiogenic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- bevacizumab, Sham bevacizumab injection
- Keywords
- CRVO, anti-VEGF, Macular edema
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Intravitreal injection of 1.25 mg bevacizumab
Sham bevacizumab injectionDrug
Sham intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal bevacizumab | Active comparator | Not described Receives: Drug: bevacizumab |
| Sham injection | Sham comparator | Not described Receives: Drug: Sham bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients gaining 15 ETDRS letters or more
Measured: 6 months
Secondary outcomes (2)
Change in foveal thickness
Measured: 6 months
Cases of neovascular glaucoma
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 posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Kvanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Kvanta, St. Erik Eye Hospital
- Investigators
- Anders Kvanta, MD, PhD, Principal investigator, St Eriks Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906685
- Sponsor's protocol ID
- ACRVO
- Status last verified
- Nov 2011
- First submitted
- 20 May 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT00906685
- Acronym / sponsor ID
- ACRVO
- Conditions
- Central Retinal Vein Occlusion
- Keywords
- CRVO, anti-VEGF, Macular edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anders KvantaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 May 2009 (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.
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal bevacizumab | Active comparator | Drug: bevacizumab |
| Sham injection | Sham comparator | Drug: Sham bevacizumab injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- CRVO with duration < 6 months
- Visual acuity of 20/800 to 20/50
Key exclusion criteria (2 listed)
- CRVO with duration of > 6 months
- previous treatment with anti-angiogenic drugs
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 |
|---|---|---|
| bevacizumabIntravitreal injection of 1.25 mg bevacizumab | Drug | Intravitreal bevacizumab |
| Sham bevacizumab injectionSham intravitreal injection | Drug | Sham injection |
Primary outcome
The proportion of patients gaining 15 ETDRS letters or more
Time frame: 6 months
2 secondary outcomes
Change in foveal thickness
Time frame: 6 months
Cases of neovascular glaucoma
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 22 Nov 2011.
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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.
Anders Kvanta, MD, PhD principal investigator
St Eriks Eye Hospital
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 Central Retinal Vein Occlusion, run by Anders Kvanta at 1 site in Sweden.
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 2 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 22 Nov 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 Sweden. 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?
The proportion of patients gaining 15 ETDRS letters or more (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 22 Nov 2011.