Neovascular Age-related Macular DegenerationPhase 3OCTAVENCT01780935
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
A Phase 3 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 92 sites in 24 countries.
Trial summary
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 671 participants
- Where
- 92 sitesin 24 countries
- Study dates
- 3 Jun 2013to 9 Jul 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visual impairment predominantly due to neovascular age-related macular degeneration AMD
- Active, newly diagnosed, untreated CNV due to AMD
- CNV involving the center of the retina
- A qualifying vision score at study entry
Who cannot join
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
Trial locations and contacts
92 sites in 24 countries.
92 sites in 24 countries
United Kingdom16 sites
Novartis Investigative Site
Belfast, BT12 6BA
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Cheshire, CW14QJ
Novartis Investigative Site
Derby, DE22 3NE
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Gloucester, GL1 3NN
Novartis Investigative Site
Great Yarmouth, NR31 6LA
Novartis Investigative Site
Guildford, Surrey, GU2 5XX
Novartis Investigative Site
Hull, HU3 2JZ
Novartis Investigative Site
London, EC1V 2PD
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Rugby, CV22 5PX
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Wolverhampton, WV10 0QP
Novartis Investigative Site
York, YO31 8HE
Germany9 sites
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Darmstadt, 64297
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
München, 80336
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Regensburg, 93053
Hungary9 sites
Novartis Investigative Site
Budapest, 1076
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1106
Novartis Investigative Site
Budapest, 1133
Novartis Investigative Site
Budapest, 1145
Novartis Investigative Site
Debrecen, 4012
Novartis Investigative Site
Szeged, H-6725
Novartis Investigative Site
Veszprém, H-8200
Novartis Investigative Site
Zalaegerszeg, 8900
Canada6 sites
Novartis Investigative Site
Boisbriand, Quebec, J7H 1S6
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2E1
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Sherbrooke, Quebec, J1J 2B8
Novartis Investigative Site
Vancouver, British Columbia, V5Z 3N9
Slovakia6 sites
Novartis Investigative Site
Bratislava, 82606
Novartis Investigative Site
Bratislava, 85107
Novartis Investigative Site
Nitra, 94901
Novartis Investigative Site
Trenčín, 91171
Novartis Investigative Site
Žilina, 01207
Novartis Investigative Site
Zvolen, 960 01
Spain5 sites
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Bilbao, Basque Country, 48006
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Oviedo, Principality of Asturias, 33012
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Czechia4 sites
Novartis Investigative Site
Brno, 625 00
Novartis Investigative Site
Hradec Králové, 505 05
Novartis Investigative Site
Olomouc, CZE, 775 20
Novartis Investigative Site
Prague, 100 34
Greece4 sites
Novartis Investigative Site
Ampelokipoi, Athens, 11 526
Novartis Investigative Site
Athens, GR, 156 69
Novartis Investigative Site
Glyfada, Athens, 16675
Novartis Investigative Site
Ioannina, 45500
Italy4 sites
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Udine, UD, 33100
Switzerland4 sites
Novartis Investigative Site
Bern, 3012
Novartis Investigative Site
Geneva, 1204
Novartis Investigative Site
Lausanne, 1007
Novartis Investigative Site
Zurich, 8063
Netherlands3 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Nijmegen, 6525 EX
Novartis Investigative Site
Rotterdam, 3011 BH
Portugal3 sites
Novartis Investigative Site
Coimbra, 3000-354
Novartis Investigative Site
Lisbon, 1050-085
Novartis Investigative Site
Porto, 4200-319
Argentina2 sites
Novartis Investigative Site
Buenos Aires, C1122AAI
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1015ABO
Colombia2 sites
Novartis Investigative Site
Bogotá, Cundinamarca, 7550000
Novartis Investigative Site
Medellín, Antioquia, 001
Finland2 sites
Novartis Investigative Site
HUS, 00029
Novartis Investigative Site
Kuopio, 70211
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01009
Novartis Investigative Site
Guatemala City, 01010
Ireland2 sites
Novartis Investigative Site
Dublin
Novartis Investigative Site
Waterford
Lithuania2 sites
Novartis Investigative Site
Kaunas, LTU, 50009
Novartis Investigative Site
Vilnius, LT-08661
Turkey (Türkiye)2 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Ankara, 06490
About this study
Official title: A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.
The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
Read the detailed description
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
- Being tested
- Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Intravitreal injections of 0.5 mg Ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| RBZ 0.5 mg: VA only (Group I) | Experimental | RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) Receives: Drug: Ranibizumab |
| RBZ 0.5 mg: VA and/or OCT (Group II) | Experimental | RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
Measured: up to Month 12
Secondary outcomes (12)
Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12
Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.
Measured: up to Month 12
Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Month 12 and 24
Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Month 3 to Month 24
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Dry Retina in the Study Eye on OCT at Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Month 12 and 24
Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Treatment Patterns Over Time in Both Treatment Arms
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Baseline to Month 12 and 24
Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Measured: Screening to Month 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study start3 Jun 2013
- Primary completion9 Jul 2015
- Study completion9 Jul 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 (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 671 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
- NCT01780935
- Sponsor's protocol ID
- CRFB002A2405
- Other IDs
- 2011-004959-39
- Acronym
- OCTAVE
- Status last verified
- Jul 2017
- First submitted
- 29 Jan 2013
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.
PubMed 31918685
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01780935
- Acronym / sponsor ID
- OCTAVE / CRFB002A2405
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 671 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 9 Jul 2015 (actual)
- Study completion
- 9 Jul 2015 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 2 Jan 2017
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 evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.
The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
Detailed description
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBZ 0.5 mg: VA only (Group I) | Experimental | Drug: RanibizumabRBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) |
| RBZ 0.5 mg: VA and/or OCT (Group II) | Experimental | Drug: RanibizumabRBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Visual impairment predominantly due to neovascular age-related macular degeneration AMD
- Active, newly diagnosed, untreated CNV due to AMD
- CNV involving the center of the retina
- A qualifying vision score at study entry
Key exclusion criteria (2 listed)
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
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 |
|---|---|---|
| RanibizumabIntravitreal injections of 0.5 mg Ranibizumab | Drug | RBZ 0.5 mg: VA and/or OCT (Group II), RBZ 0.5 mg: VA only (Group I) |
Primary outcome
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
Time frame: up to Month 12
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
12 secondary outcomes
Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12
Time frame: up to Month 12
Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24
Time frame: Baseline to Month 12 and 24
Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24
Time frame: Baseline to Month 12 and 24
Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24
Time frame: Month 12 and 24
Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye
Time frame: Month 3 to Month 24
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye
Time frame: Baseline to Month 12 and 24
Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time
Time frame: Baseline to Month 12 and 24
Dry Retina in the Study Eye on OCT at Month 12 and 24
Time frame: Month 12 and 24
Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24
Time frame: Baseline to Month 12 and 24
Treatment Patterns Over Time in Both Treatment Arms
Time frame: Baseline to Month 12 and 24
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time
Time frame: Baseline to Month 12 and 24
Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time
Time frame: Screening to Month 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31918685Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.
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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
92 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 92 sites in 24 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 4 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United Kingdom, Germany, Hungary, Canada, Slovakia and 19 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 2 Jan 2017). 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?
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 (time frame: up to Month 12). 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 NCT01780935, 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 14 Aug 2017.