Retinal Vein OcclusionPhase 4NCT01027481
Ranibizumab in Patients With Branch Retinal Vein Occlusion
A Phase 4 study testing Lucentis in people with Retinal Vein Occlusion, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Lucentis
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, at least 18 years of age.
- ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months.
- macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment.
- retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.
- VA decrease attributable to the edema.
- written informed consent has been obtained.
- female patients of childbearing potential must have a negative urine pregnancy test.
Who cannot join
- Uncontrolled sytemic disease
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia)
- History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios.
- contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)
In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.
Read the detailed description
To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months.
Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO
30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™)
Main outcome measure: Retinal vessel diameters
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Lucentis
- Keywords
- lucentis, macular edema, branch 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.
LucentisDrug
Also called RANIBIZUMAB (Lucentis 0.05 ml, Novartis)
intravitreally administration of 0.05 ml Lucentis
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measure: Retinal vessel diameters
Measured: weeks 1, 4 and 16
Secondary outcomes (1)
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.
Measured: weeks 1,4 and16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startDec 2007
- Primary completionNov 2009
- Study completionDec 2009
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 Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Sacu, Ass. Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027481
- Sponsor's protocol ID
- V1
- Status last verified
- Nov 2007
- First submitted
- 7 Dec 2009
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sacu S, Pemp B, Weigert G, Matt G, Garhofer G, Pruente C, Schmetterer L, Schmidt-Erfurth U. Response of retinal vessels and retrobulbar hemodynamics to intravitreal anti-VEGF treatment in eyes with branch retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3046-50. doi: 10.1167/iovs.10-5842.
PubMed 21051706
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)
- ClinicalTrials.gov ID
- NCT01027481
- Acronym / sponsor ID
- V1
- Conditions
- Retinal Vein Occlusion
- Keywords
- lucentis, macular edema, branch retinal vein occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 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.
In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.
Detailed description
To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months.
Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO
30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™)
Main outcome measure: Retinal vessel diameters
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female, at least 18 years of age.
- ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months.
- macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment.
- retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.
- VA decrease attributable to the edema.
Key exclusion criteria (5 listed)
- Uncontrolled sytemic disease
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia)
- History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios.
- contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.
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 |
|---|---|---|
| LucentisAlso: RANIBIZUMAB (Lucentis 0.05 ml, Novartis)intravitreally administration of 0.05 ml Lucentis | Drug | – |
Primary outcome
Main outcome measure: Retinal vessel diameters
Time frame: weeks 1, 4 and 16
1 secondary outcome
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.
Time frame: weeks 1,4 and16
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 8 Dec 2009.
- Derived from this study: PubMed 21051706Sacu S, Pemp B, Weigert G, Matt G, Garhofer G, Pruente C, Schmetterer L, Schmidt-Erfurth U. Response of retinal vessels and retrobulbar hemodynamics to intravitreal anti-VEGF treatment in eyes with branch retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3046-50. doi: 10.1167/iovs.10-5842.
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.
Stefan Sacu, Ass. Prof. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lucentis in people with Retinal Vein Occlusion, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 5 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 8 Dec 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Main outcome measure: Retinal vessel diameters (time frame: weeks 1, 4 and 16). 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 NCT01027481, 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 8 Dec 2009.