Branch Retinal Vein OcclusionPhase 3BRIGHTERNCT01599650
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
A Phase 3 study testing Ranibizumab and Laser in people with Branch Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 82 sites in 17 countries.
Trial summary
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Ranibizumab and Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 82 sitesin 17 countries
- Study dates
- May 2012to May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Who cannot join
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
- Neovascularization of the iris or neovascular glaucoma in the study eye
Show all 11Show fewer
- Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
- Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
- Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
- Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
- Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye
Trial locations and contacts
82 sites in 17 countries.
82 sites in 17 countries
Spain10 sites
Novartis Investigative Site
Alicante, Valencia, 03016
Novartis Investigative Site
Barcelona, Catalonia, 08022
Novartis Investigative Site
Barcelona, Catalonia
Novartis Investigative Site
Bilbao, Basque Country, 48006
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, Madrid, 28046
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Valencia, Valencia, 46014
Novartis Investigative Site
Valencia, Valencia, 46015
Novartis Investigative Site
Valladolid, Castille and León, 47011
United Kingdom9 sites
Novartis Investigative Site
Belfast, BT12 6BA
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
London, United Kingdom, EC1V 2PD
Novartis Investigative Site
London, NW1 5QH
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Plymouth, PL4 6PL
Novartis Investigative Site
Southampton, SO16 6YD
Italy8 sites
Novartis Investigative Site
Bari, 70124
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Roma, RM, 00144
Novartis Investigative Site
Torino, TO, 10122
Novartis Investigative Site
Udine, 33100
Canada7 sites
Novartis Investigative Site
Boisbriand, Quebec, J7H 1S6
Novartis Investigative Site
Calgary, Alberta, T2H0C8
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1M9
Novartis Investigative Site
Victoria, British Columbia, V8V 4X3
France6 sites
Novartis Investigative Site
Dijon, 21033
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Nice, 06000
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75940
Novartis Investigative Site
Paris
Greece6 sites
Novartis Investigative Site
Athens, GR, 124 62
Novartis Investigative Site
Heraklion Crete, GR, 711 10
Novartis Investigative Site
Larissa, GR, 411 10
Novartis Investigative Site
Pátrai, Greece, 26504
Novartis Investigative Site
Thessaloniki, Greece, GR 54636
Novartis Investigative Site
Thessaloniki, GR, 546 29
Poland6 sites
Novartis Investigative Site
Bielsko-Biala, 43-300
Novartis Investigative Site
Gdansk, 80-809
Novartis Investigative Site
Krakow, 31-501
Novartis Investigative Site
Lublin, 20-079
Novartis Investigative Site
Warsaw, 02-005
Novartis Investigative Site
Wroclaw, 50-556
Portugal6 sites
Novartis Investigative Site
Coimbra, Portugal, 3000-354
Novartis Investigative Site
Coimbra, Portugal, 3030-163
Novartis Investigative Site
Lisbon, 1050-085
Novartis Investigative Site
Lisbon, 1349-019
Novartis Investigative Site
Porto, Porto District, 4200-319
Novartis Investigative Site
Porto, Portugal, 4099-001
Australia4 sites
Novartis Investigative Site
Melbourne, Victoria, 3002
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Parramatta, New South Wales, 2150
Novartis Investigative Site
Sydney, New South Wales, 2000
Slovakia4 sites
Novartis Investigative Site
Banská Bystrica, 975 17
Novartis Investigative Site
Bratislava, Slovakia, 826 06
Novartis Investigative Site
Bratislava, 851 07
Novartis Investigative Site
Žilina, Slovak Republic, 010 01
Switzerland4 sites
Novartis Investigative Site
Bern, 3012
Novartis Investigative Site
Lausanne, 1007
Novartis Investigative Site
Olten, Switzerland, 4600
Novartis Investigative Site
Zurich, Switzerland, 8063
Hungary3 sites
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Budapest, H-1083
Novartis Investigative Site
Debrecen, 4032
Netherlands3 sites
Novartis Investigative Site
Leiden 2333 ZA, Netherlands, 2333
Novartis Investigative Site
Rotterdam, 3011 BH
Novartis Investigative Site
Tilburg, 5022 GC
Czechia2 sites
Novartis Investigative Site
Olomouc, 775 20
Novartis Investigative Site
Prague, 100 34
Ireland2 sites
Novartis Investigative Site
Dublin, Ireland
Novartis Investigative Site
Dublin
About this study
Official title: A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Ranibizumab, Laser
- Keywords
- Macular Edema, Branch Retinal Vein Occlusion, visual impairment
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
LaserProcedure or surgery
laser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| 1-ranibizumab monotherapy | Experimental | Ranibizumab 0.5 mg Receives: Drug: Ranibizumab |
| 2-ranibizumab with laser | Experimental | Ranibizumab 0.5 mg + laser Receives: Drug: Ranibizumab; Procedure: Laser |
| 3-laser monotherapy | Active comparator | Laser monotherapy with Ranibizumab 0.5 mg from Month 6 Receives: Procedure: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)
-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
Measured: Baseline, 6 Months
Secondary outcomes (10)
The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.
Measured: Baseline, 24 Months
Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group
Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.
Measured: Day 1 through Month 23
Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.
Measured: From Baseline through Month 6
The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.
Measured: Baseline, Month 12 and Month 24
The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 \& Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).
Measured: Baseline, Month 6 and Month 24
Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.
Measured: Month 6
Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.
Measured: Month 24
The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity \& analysis was based on analysis of variance (ANOVA)
Measured: Month 12 and Month 24
The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline
The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
Measured: Months 6 and 24
BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)
-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Branch Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599650
- Sponsor's protocol ID
- CRFB002E2402
- Other IDs
- 2011-002859-34
- Acronym
- BRIGHTER
- Status last verified
- Sep 2016
- First submitted
- 2 May 2012
- Last updated
- 10 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.
PubMed 34934034Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12.
PubMed 28807635Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.
PubMed 27039022
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01599650
- Acronym / sponsor ID
- BRIGHTER / CRFB002E2402
- Conditions
- Branch Retinal Vein Occlusion
- Keywords
- Macular Edema, Branch Retinal Vein Occlusion, visual impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 10 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-ranibizumab monotherapy | Experimental | Drug: RanibizumabRanibizumab 0.5 mg |
| 2-ranibizumab with laser | Experimental | Drug: Ranibizumab, Procedure: LaserRanibizumab 0.5 mg + laser |
| 3-laser monotherapy | Active comparator | Procedure: LaserLaser monotherapy with Ranibizumab 0.5 mg from Month 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent must be obtained before any study assessment is performed
- Diagnosis of visual impairment exclusively due to ME secondary to BRVO
- BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Key exclusion criteria (11 listed)
- Pregnant or nursing (lactating) women
- Stroke or myocardial infarction less than 3 months before Screening
- Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
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 | Drug | 1-ranibizumab monotherapy, 2-ranibizumab with laser |
| Laserlaser photocoagulation | Procedure or surgery | 2-ranibizumab with laser, 3-laser monotherapy |
Primary outcome
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)
Time frame: Baseline, 6 Months
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.
10 secondary outcomes
The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline
Time frame: Baseline, 24 Months
Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group
Time frame: Day 1 through Month 23
Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6
Time frame: From Baseline through Month 6
The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24
Time frame: Baseline, Month 12 and Month 24
The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit
Time frame: Baseline, Month 6 and Month 24
Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye
Time frame: Month 6
Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye
Time frame: Month 24
The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm
Time frame: Month 12 and Month 24
The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline
Time frame: Months 6 and 24
BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34934034Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.
- Derived from this study: PubMed 28807635Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12.
- Derived from this study: PubMed 27039022Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
82 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab and Laser in people with Branch Retinal Vein Occlusion, run by Novartis Pharmaceuticals at 82 sites in 17 countries.
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 3 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: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in Spain, United Kingdom, Italy, Canada, France and 12 more countries. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (time frame: Baseline, 6 Months). 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 NCT01599650, which also lists 3 linked publications.
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 10 Nov 2016.