Branch Retinal Vein OcclusionPhase 3NCT00642226
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
A Phase 3 study testing Grid Laser and Vitrectomy and 20 mg triamcinolone in people with Branch Retinal Vein Occlusion and Macular Edema, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion, Macular Edema
- What is being tested?
- Grid Laser and Vitrectomy and 20 mg triamcinolone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2006to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular edema secondary to BRVO
- Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
- Duration no shorter than 3 months
- Duration no longer than 12 months
Who cannot join
- Proliferations in study eye
- Blod in vitreous cavity
- Previous fundus laser treatment
- BRVO with over 180˚ of ischemia on FA
- Age under 18
- Other eye condition which contribute to relevant loss of visual acuity
Trial locations and contacts
1 site in 1 country.
Norway1 site
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4018
About this study
Official title: A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.
- Conditions
- Branch Retinal Vein Occlusion, Macular Edema
- Being tested
- Grid Laser, Vitrectomy and 20 mg triamcinolone
- Keywords
- Branch Retinal Vein Occlusion, BRVO, Macular Edema, Triamcinolone, Vitrectomy
- 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.
Grid LaserProcedure or surgery
Also called Laser photocoagulation of macular edema
ETDRS Grid Laser
Vitrectomy and 20 mg triamcinoloneProcedure or surgery
Also called PPV with induction of posterior vitreous detachment
Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Grid Laser Receives: Procedure: Grid Laser |
| 2 | Experimental | Vitrectomy in combination with 20 mg triamcinolone Receives: Procedure: Vitrectomy and 20 mg triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (ETDRS)
Measured: 12 and 36 Months
Secondary outcomes (1)
Retinal thickening measured on OCT.
Measured: 12 and 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Johan Seland, PhD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642226
- Sponsor's protocol ID
- 3.2006.1159(REK)
- Other IDs
- 3.2006.1159, 14836
- Status last verified
- Jan 2014
- First submitted
- 19 Mar 2008
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
- ClinicalTrials.gov ID
- NCT00642226
- Acronym / sponsor ID
- 3.2006.1159(REK)
- Conditions
- Branch Retinal Vein Occlusion, Macular Edema
- Keywords
- Branch Retinal Vein Occlusion, BRVO, Macular Edema, Triamcinolone, Vitrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Nov 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Mar 2008 (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 determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Grid LaserGrid Laser |
| 2 | Experimental | Procedure: Vitrectomy and 20 mg triamcinoloneVitrectomy in combination with 20 mg triamcinolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Macular edema secondary to BRVO
- Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
- Duration no shorter than 3 months
- Duration no longer than 12 months
Key exclusion criteria (6 listed)
- Proliferations in study eye
- Blod in vitreous cavity
- Previous fundus laser treatment
- BRVO with over 180˚ of ischemia on FA
- Age under 18
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 |
|---|---|---|
| Grid LaserAlso: Laser photocoagulation of macular edemaETDRS Grid Laser | Procedure or surgery | 1 |
| Vitrectomy and 20 mg triamcinoloneAlso: PPV with induction of posterior vitreous detachmentPars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate | Procedure or surgery | 2 |
Primary outcome
Visual acuity (ETDRS)
Time frame: 12 and 36 Months
1 secondary outcome
Retinal thickening measured on OCT.
Time frame: 12 and 36 Months
Results and safety
The study was stopped early (reason given: Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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.
Johan Seland, PhD study director
Helse Stavanger HF
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 Grid Laser and Vitrectomy and 20 mg triamcinolone in people with Branch Retinal Vein Occlusion and Macular Edema, run by Helse Stavanger HF at 1 site in Norway.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Jan 2014. 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 Norway. 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 was stopped early (reason given: Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).). Results are not available in the source record.
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 (ETDRS) (time frame: 12 and 36 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 6 Jan 2014.