Wet Age Related Macular DegenerationPhase 4TWEYESNCT01986907
Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye
A Phase 4 study testing ranibizumab in people with Wet Age Related Macular Degeneration, run by Novartis Pharmaceuticals at 101 sites in Italy.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet 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
- 1,049 participants
- Where
- 101 sitesItaly
- Study dates
- 4 Mar 2014to 15 Jun 2016
- Phase
- Phase 4
- 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
- Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
Who cannot join
- Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
Trial locations and contacts
101 sites in 1 country.
101 sites in 1 country
Italy101 sites
Novartis Investigative Site
Acireale, CT, 95024
Novartis Investigative Site
Acquaviva delle Fonti, BA, 70021
Novartis Investigative Site
Alessandria, AL, 15100
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Belluno, BL, 32100
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Bolzano, BZ, 39100
Novartis Investigative Site
Borgomanero, 28021
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Busto Arsizio, VA, 21052
Novartis Investigative Site
Cagliari, CA, 09124
Novartis Investigative Site
Camposampiero, PD, 35012
Novartis Investigative Site
Casale Monferrato, AL, 15033
Novartis Investigative Site
Caserta, CE, 81100
Novartis Investigative Site
Catania, CT, 95123
Novartis Investigative Site
Catania, CT, 95124
Novartis Investigative Site
Catanzaro, CZ, 88100
Novartis Investigative Site
Ceva, CN, 12073
Novartis Investigative Site
Chieti, CH, 66100
Novartis Investigative Site
Cinisello Balsamo, MI, 20092
Novartis Investigative Site
Città di Castello, PG, 06012
Novartis Investigative Site
Civitavecchia, RM, 00053
Novartis Investigative Site
Como, CO, 22100
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Conegliano, TV, 31015
Novartis Investigative Site
Correggio, RE, 42015
Novartis Investigative Site
Crotone, KR, 88074
Novartis Investigative Site
Cuneo, CN, 12100
Novartis Investigative Site
Desenzano del Garda, BS, 25015
Novartis Investigative Site
Eboli, SA, 84025
Novartis Investigative Site
Foggia, FG, 71100
Novartis Investigative Site
Foligno, PG, 06034
Novartis Investigative Site
Forlì, FC, 47100
Novartis Investigative Site
Galliate, 28066
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Genova, GE, 16153
Novartis Investigative Site
Larino, CB
Novartis Investigative Site
Legnago, VR, 37045
Novartis Investigative Site
Legnano, MI, 20025
Novartis Investigative Site
Messina, ME, 98125
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20123
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20142
Novartis Investigative Site
Milazzo, ME, 98057
Novartis Investigative Site
Monselice, PD, 35043
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Naples, 80132
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Negrar, VR, 37024
Novartis Investigative Site
Nuoro, NU, 08100
Novartis Investigative Site
Padova, PD, 35100
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90127
Novartis Investigative Site
Palermo, PA, 90146
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Perugia, PG, 06100
Novartis Investigative Site
Pescara, PE, 65124
Novartis Investigative Site
Piacenza, PC, 29100
Novartis Investigative Site
Pordenone, PN, 33170
Novartis Investigative Site
Pozzuoli, 80078
Novartis Investigative Site
Putignano, BA, 70017
Novartis Investigative Site
Rapallo, GE, 16035
Novartis Investigative Site
Reggio Calabria, RC, 89124
Novartis Investigative Site
Reggio Emilia, RE, 42123
Novartis Investigative Site
Riccione, RN, 47838
Novartis Investigative Site
Roma, RM, 00133
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Roma, RM, 00184
Novartis Investigative Site
Roma, RM, 00186
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Salerno, SA, 84131
Novartis Investigative Site
San Feramo Della Battaglia, CO, 22020
Novartis Investigative Site
San Giovanni Rotondo, FG, 71013
Novartis Investigative Site
Santorso, VI, 36014
Novartis Investigative Site
Sarzana, SP, 19038
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Savona, SV, 17100
Novartis Investigative Site
Somma Lombardo, VA, 21019
Novartis Investigative Site
Sondrio, SO, 23100
Novartis Investigative Site
Taranto, TA, 74100
Novartis Investigative Site
Teramo, TE, 64100
Novartis Investigative Site
Terlizzi, BA, 70038
Novartis Investigative Site
Terni, TR, 05100
Novartis Investigative Site
Terracina, LT, 04019
Novartis Investigative Site
Torino, TO, 10122
Novartis Investigative Site
Torino, TO, 10152
Novartis Investigative Site
Torino, TO, 10153
Novartis Investigative Site
Treviso, TV, 31100
Novartis Investigative Site
Tricase, LE, 73039
Novartis Investigative Site
Trieste, TS, 34129
Novartis Investigative Site
Udine, UD, 33100
Novartis Investigative Site
Varese, VA, 21100
Novartis Investigative Site
Verona, VR, 37126
Novartis Investigative Site
Vicenza, VI, 36100
Novartis Investigative Site
Vizzolo Predabissi, MI, 20070
About this study
Official title: A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
- Conditions
- Wet Age Related Macular Degeneration
- Being tested
- ranibizumab
- Keywords
- wet AMD, macular degeneration, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors, Angiogenesis Modulating Agents
- Medical subject headings
- Macular Degeneration, Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Administered as an Intravitreal injection Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Systemic Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Measured: Baseline to Month 12
Number of Eyes With Ocular Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Measured: Baseline to Month 12
Secondary outcomes (3)
Overall Number of Ranibizumab Injections
Measured: Baseline to month 12
Time Interval Between Injections in Bilateral Disease
Mean number of days between two consecutive injections per eye
Measured: Baseline to month 12
Mean Number of Injections Per Patient
Number of injections per patient
Measured: Baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study start4 Mar 2014
- Primary completion15 Jun 2016
- Study completion15 Jun 2016
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.
- Other trials for Wet 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,049 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
- NCT01986907
- Sponsor's protocol ID
- CRFB002AIT02
- Other IDs
- 2013-003333-15
- Acronym
- TWEYES
- Status last verified
- May 2019
- First submitted
- 12 Nov 2013
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye
- ClinicalTrials.gov ID
- NCT01986907
- Acronym / sponsor ID
- TWEYES / CRFB002AIT02
- Conditions
- Wet Age Related Macular Degeneration
- Keywords
- wet AMD, macular degeneration, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2014 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Posted 19 Jul 2019
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 evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: ranibizumabAdministered as an Intravitreal injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
Key exclusion criteria (1 listed)
- Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
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 |
|---|---|---|
| ranibizumabAll patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). | Drug | Ranibizumab |
Primary outcome
Number of Participants With Systemic Drug-related Adverse Events
Time frame: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
Number of Eyes With Ocular Drug-related Adverse Events
Time frame: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
3 secondary outcomes
Overall Number of Ranibizumab Injections
Time frame: Baseline to month 12
Time Interval Between Injections in Bilateral Disease
Time frame: Baseline to month 12
Mean Number of Injections Per Patient
Time frame: Baseline to month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
101 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranibizumab in people with Wet Age Related Macular Degeneration, run by Novartis Pharmaceuticals at 101 sites in Italy.
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 1 inclusion and 1 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in Italy. 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?
Yes. Results are posted in the registry (first posted 19 Jul 2019). 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?
Number of Participants With Systemic Drug-related Adverse Events (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. 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 19 Jul 2019.