Retinal Vein OcclusionPhase 2BRAVONCT01123564
Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
A Phase 2 study testing ranibizumab and Argon laser treatment in people with Retinal Vein Occlusion and Macular Edema, run by University of Pecs at 2 sites in Hungary.
Trial summary
This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- ranibizumab and Argon laser treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesHungary
- Study dates
- Aug 2009to Sep 2011
- Phase
- Phase 2
- 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 persisting for more than 3 months period despite conventional medication.
- Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
- Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
- Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
- Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).
Who cannot join
- Diabetes mellitus
- Additional vitreoretinal diseases
- History of pars plana vitrectomy
- Previous macular grid laser treatment
- Intravitreal triamcinolone acetonid treatment
- Complicated cataract surgery
Show all 11Show fewer
- Advanced glaucomatous damage of optic nerve head
- Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
- Age-related macular degeneration
- Pregnancy and lactation
- Women in childbearing potential who are not using double safe contraception
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites, 2 recruiting
- Recruiting
Debrecen Medical and Health Science Center Dept of Ophthalmology
Debrecen, H-4012
Attila Vajas, MD, vajasa@gmail.com
Attila Vajas, MD
- Recruiting
University of Pecs, Medical School, Department of Ophthalmology
Pécs, H-7624
Zsolt Balla, MD, +3672536141, balla07@freemail.hu
Zsolt Balla, MD PhD
About this study
Official title: A Randomized, Controlled, Two-center Phase II Study Assessing the Efficacy and Safety of Intravitreal Lucentis Injections in Patients With Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- ranibizumab, Argon laser treatment
- Keywords
- macular edema secondary to retinal vein occlusion
- 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.
ranibizumabDrug
Also called Lucentis intravitreal injection
applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
Argon laser treatmentRadiation
Also called Laser photocoagulation
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
| Study group | Role | What they receive |
|---|---|---|
| Lucentis (ranibizumab) | Experimental | Not described Receives: Drug: ranibizumab |
| Laser | Active comparator | Not described Receives: Radiation: Argon laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly.
Measured: 12 months
Secondary outcomes (1)
Efficacy assessed by change in macular thickness
The efficacy of treatment concerning change of anatomical structure of macular region detected by Optical Coherence Tomography (OCT) - the mean change of macular thickness (micron) at each months of 1 year period.
Measured: 12 months with monthly assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen
- Investigators
- Zsolt Balla, MD PhD, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123564
- Sponsor's protocol ID
- CRFB002AHU02T
- Acronym
- BRAVO
- Status last verified
- May 2010
- First submitted
- 12 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Two-center Phase II Study Assessing the Efficacy and Safety of Intravitreal Lucentis Injections in Patients With Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01123564
- Acronym / sponsor ID
- BRAVO / CRFB002AHU02T
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Keywords
- macular edema secondary to retinal vein occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- University of Debrecen
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 14 May 2010 (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 assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to 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 |
|---|---|---|
| Lucentis (ranibizumab) | Experimental | Drug: ranibizumab |
| Laser | Active comparator | Radiation: Argon laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Macular edema persisting for more than 3 months period despite conventional medication.
- Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
- Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
- Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
- Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).
Key exclusion criteria (11 listed)
- Diabetes mellitus
- Additional vitreoretinal diseases
- History of pars plana vitrectomy
- Previous macular grid laser treatment
- Intravitreal triamcinolone acetonid treatment
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 |
|---|---|---|
| ranibizumabAlso: Lucentis intravitreal injectionapplied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits | Drug | Lucentis (ranibizumab) |
| Argon laser treatmentAlso: Laser photocoagulationConventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis. | Radiation | Laser |
Primary outcome
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)
Time frame: 12 months
To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly.
1 secondary outcome
Efficacy assessed by change in macular thickness
Time frame: 12 months with monthly assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
Related trials for Retinal Vein Occlusion
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
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.
Zsolt Balla, MD PhD principal investigator
University of Pecs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ranibizumab and Argon laser treatment in people with Retinal Vein Occlusion and Macular Edema, run by University of Pecs at 2 sites in Hungary.
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 11 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 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zsolt Balla, MD (+3672536141, balla07@freemail.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity) (time frame: 12 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 14 May 2010.