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AzTrials

Age-related Macular DegenerationPhase 3TRENDNCT01948830

Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

A Phase 3 study testing Ranibizumab 0.5mg in people with Age-related Macular Degeneration and Choroidal Neovascularization, run by Novartis Pharmaceuticals at 91 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ranibizumab 0.5mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
91 sitesin 19 countries
Study dates
17 Dec 2013to 19 Nov 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

  • Male or female patients, ≥50 years of age with signed informed consent before study procedures
  • Visual impairment predominantly due to nAMD.
  • Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography
  • Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT
  • BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)

Who cannot join

  • Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
  • Stroke or myocardial infarction within 3 months prior to Screening.
  • Any active periocular or ocular infection or inflammation in both eyes.
  • Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity.
  • Presence of amblyopia or amaurosis in the fellow eye.
  • History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye.
  • History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening.
  • Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Trial locations and contacts

91 sites in 19 countries.

91 sites in 19 countries

Germany16 sites

  • Novartis Investigative Site

    Ahaus, 48683

  • Novartis Investigative Site

    Augsburg, 86156

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Darmstadt, 64297

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Karlsruhe, 76199

  • Novartis Investigative Site

    Leipzig, Germany, 04103

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Siegburg, 53721

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Sulzbach, 66280

Other trials in Germany

Hungary10 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

    Budapest, H-1115

  • Novartis Investigative Site

    Debrecen, 4012

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, H-6725

  • Novartis Investigative Site

    Zalaegerszeg, 8900

Other trials in Hungary

Italy8 sites

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Roma, RM, 00198

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

United Kingdom8 sites

  • Novartis Investigative Site

    Belfast, BT12 6BA

  • Novartis Investigative Site

    Bristol, BS1 2LX

  • Novartis Investigative Site

    Frimley, Surrey, GU16 7UJ

  • Novartis Investigative Site

    Guildford, Surrey, GU2 5XX

  • Novartis Investigative Site

    London, EC1V 2PD

  • Novartis Investigative Site

    Manchester, M13 9WL

  • Novartis Investigative Site

    Sunderland, SR2 9HP

  • Novartis Investigative Site

    Uxbridge, London, UB8 3NN

Other trials in United Kingdom

Spain6 sites

  • Novartis Investigative Site

    Barcelona, Barcelona, 08025

  • Novartis Investigative Site

    Barcelona, Catalonia, 08022

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33012

  • Novartis Investigative Site

    Sant Cugat del Vallès, Catalonia, 08190

  • Novartis Investigative Site

    Valladolid, Castille and León, 47011

  • Novartis Investigative Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Israel5 sites

  • Novartis Investigative Site

    Haifa, 3525408

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Portugal5 sites

  • Novartis Investigative Site

    Coimbra, Portugal, 3000-354

  • Novartis Investigative Site

    Coimbra, Portugal, 3030-163

  • Novartis Investigative Site

    Lisbon, Portugal, 1150-314

  • Novartis Investigative Site

    Porto, Portugal, 4099-001

  • Novartis Investigative Site

    Vila Franca de Xira, Portugal, 2600-009

Other trials in Portugal

Russia5 sites

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    Moscow, 119021

  • Novartis Investigative Site

    Moscow, 127486

  • Novartis Investigative Site

    Novosibirsk, 630071

  • Novartis Investigative Site

    Samara, 443068

Other trials in Russia

Slovakia5 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovakia, 97517

  • Novartis Investigative Site

    Bratislava, 82606

  • Novartis Investigative Site

    Nové Zámky, Slovakia, 94001

  • Novartis Investigative Site

    Poprad, Slovakia, 05845

  • Novartis Investigative Site

    Žilina, Slovakia, 01207

Other trials in Slovakia

South Korea4 sites

  • Novartis Investigative Site

    Busan, Busan, 49241

  • Novartis Investigative Site

    Seongnam-si, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 06591

Other trials in South Korea

Switzerland4 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Bern, 3012

  • Novartis Investigative Site

    Lausanne, 1007

  • Novartis Investigative Site

    Zurich, 8063

Other trials in Switzerland

Belgium3 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Ottignies, 1340

  • Novartis Investigative Site

    Zottegem, 9620

Other trials in Belgium

India3 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560010

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600 006

  • Novartis Investigative Site

    Vanchiyoor, Thiruvanantapuram, 695035

Other trials in India

Denmark2 sites

  • Novartis Investigative Site

    Glostrup Municipality, 2600

  • Novartis Investigative Site

    Roskilde, 4000

Other trials in Denmark

Egypt2 sites

  • Novartis Investigative Site

    Cairo, Abbassia

  • Novartis Investigative Site

    Cairo

Other trials in Egypt

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06490

  • Novartis Investigative Site

    Ankara, 06100

Other trials in Turkey (Türkiye)

Chile1 site

  • Novartis Investigative Site

    Santiago, 7650018

Other trials in Chile

Croatia1 site

  • Novartis Investigative Site

    Zagreb, Croatia, 10000

Other trials in Croatia

Slovenia1 site

  • Novartis Investigative Site

    Ljubljana, Slovenia, 1000

Other trials in Slovenia

About this study

Official title: A 12-month, Phase 3b, Randomized, Visual Acuity Assessor-masked, Multicenter Study Assessing the Efficacy and Safety of Ranibizumab 0.5mg in Treat and Extend Regimen Compared to Monthly Regimen, in Patients With Neovascular Age-related Macular Degeneration

This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

Read the detailed description

This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.

There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.

Being tested
Ranibizumab 0.5mg
Keywords
Ranibizumab, Lucentis, choroidal neovascularization, age-related macular degeneration, treat and extend regimen
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranibizumab 0.5mgDrug

    Also called Lucentis

    0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

  • Ranibizumab 0.5mgDrug

    Also called Lucentis

    0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Study groups in NCT01948830
Study groupRoleWhat they receive
Group I ranibizumab 0.5 mg monthlyActive comparatorRanibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11
Receives: Drug: Ranibizumab 0.5mg
Group II ranibizumab 0.5 mg TERActive comparatorRanibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11
Receives: Drug: Ranibizumab 0.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts 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

    Measured: Baseline to month 12

Secondary outcomes (13)

  1. Number of Visits Scheduled

    The number of visits scheduled according to the treat and extend regimen after treatment initiation

    Measured: From Month1 to Month 11

  2. Change in BCVA From Baseline to Month 12

    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

    Measured: Baseline to Month 12

  3. Average BCVA Change From Baseline to Month 12

    Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

    Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12

    Measured: Baseline and every month for 12 months

  4. Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12

    Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts 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 compare to Baseline

    Measured: Baseline and every month for 12 months

  5. Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12

    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 12 as compared with baseline

    Measured: Baseline and every month for 12 months

  6. Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit

    Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

    Measured: Baseline and every month for 12 months

  7. Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12

    Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts 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 12 indicates a positive outcome

    Measured: Baseline and every month for 12 months

  8. The Mean Number of Treatment Frequency

    The number of injections received

    Measured: Month 12

  9. The Average Number of Days Between Injections

    The average dosing interval was measured as the average number of days between injections

    Measured: Month 12

  10. Percentage of Participants With Fluid Free Macula Over Time up to Month 12

    OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages

    Measured: Month 12

  11. Change in Central Subfield Retinal Thickness (CSFT) Over Time

    OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit

    Measured: Month 12

  12. Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at

    To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.

    Measured: Month 12

  13. Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)

    The survey consisted 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. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study start17 Dec 2013
  3. Primary completion19 Nov 2015
  4. Study completion19 Nov 2015

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01948830
Sponsor's protocol ID
CRFB002A2411
Other IDs
2013-002626-23
Acronym
TREND
Status last verified
Mar 2017
First submitted
19 Sep 2013
Last updated
17 Apr 2017
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 34934034

  • Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.

    PubMed 32374423

  • Waldstein SM, Coulibaly L, Riedl S, Sadeghipour A, Gerendas BS, Schmidt-Erfurth UM. Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration. Br J Ophthalmol. 2020 Jul;104(7):899-903. doi: 10.1136/bjophthalmol-2019-314661. Epub 2019 Sep 28.

    PubMed 31563866

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab 0.5mg in people with Age-related Macular Degeneration and Choroidal Neovascularization, run by Novartis Pharmaceuticals at 91 sites in 19 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 5 inclusion and 8 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Germany, Hungary, Italy, United Kingdom, Spain and 14 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 15 Dec 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?

Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 (time frame: Baseline 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 NCT01948830, 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 17 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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