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 (TWEYES)

May 11, 2019 updated by: Novartis Pharmaceuticals

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1049

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Borgomanero, Italy, 28021
        • Novartis Investigative Site
      • Galliate, Italy, 28066
        • Novartis Investigative Site
      • Napoli, Italy, 80131
        • Novartis Investigative Site
      • Napoli, Italy, 80132
        • Novartis Investigative Site
      • Napoli, Italy, 80138
        • Novartis Investigative Site
      • Pozzuoli, Italy, 80078
        • Novartis Investigative Site
    • AL
      • Alessandria, AL, Italy, 15100
        • Novartis Investigative Site
      • Casale Monferrato, AL, Italy, 15033
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italy, 60126
        • Novartis Investigative Site
    • BA
      • Acquaviva delle Fonti, BA, Italy, 70021
        • Novartis Investigative Site
      • Putignano, BA, Italy, 70017
        • Novartis Investigative Site
      • Terlizzi, BA, Italy, 70038
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Novartis Investigative Site
    • BL
      • Belluno, BL, Italy, 32100
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
      • Desenzano del Garda, BS, Italy, 25015
        • Novartis Investigative Site
    • BZ
      • Bolzano, BZ, Italy, 39100
        • Novartis Investigative Site
    • CA
      • Cagliari, CA, Italy, 09124
        • Novartis Investigative Site
    • CB
      • Larino, CB, Italy
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Novartis Investigative Site
    • CH
      • Chieti, CH, Italy, 66100
        • Novartis Investigative Site
    • CN
      • Ceva, CN, Italy, 12073
        • Novartis Investigative Site
      • Cuneo, CN, Italy, 12100
        • Novartis Investigative Site
    • CO
      • Como, CO, Italy, 22100
        • Novartis Investigative Site
      • San Feramo Della Battaglia, CO, Italy, 22020
        • Novartis Investigative Site
    • CT
      • Acireale, CT, Italy, 95024
        • Novartis Investigative Site
      • Catania, CT, Italy, 95124
        • Novartis Investigative Site
      • Catania, CT, Italy, 95123
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Novartis Investigative Site
    • FC
      • Forlì, FC, Italy, 47100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44100
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italy, 71100
        • Novartis Investigative Site
      • San Giovanni Rotondo, FG, Italy, 71013
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
      • Genova, GE, Italy, 16153
        • Novartis Investigative Site
      • Rapallo, GE, Italy, 16035
        • Novartis Investigative Site
    • KR
      • Crotone, KR, Italy, 88074
        • Novartis Investigative Site
    • LE
      • Tricase, LE, Italy, 73039
        • Novartis Investigative Site
    • LT
      • Terracina, LT, Italy, 04019
        • Novartis Investigative Site
    • ME
      • Messina, ME, Italy, 98125
        • Novartis Investigative Site
      • Milazzo, ME, Italy, 98057
        • Novartis Investigative Site
    • MI
      • Cinisello Balsamo, MI, Italy, 20092
        • Novartis Investigative Site
      • Legnano, MI, Italy, 20025
        • Novartis Investigative Site
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
      • Milano, MI, Italy, 20123
        • Novartis Investigative Site
      • Milano, MI, Italy, 20100
        • Novartis Investigative Site
      • Milano, MI, Italy, 20142
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
      • Vizzolo Predabissi, MI, Italy, 20070
        • Novartis Investigative Site
    • NU
      • Nuoro, NU, Italy, 08100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
      • Palermo, PA, Italy, 90146
        • Novartis Investigative Site
    • PC
      • Piacenza, PC, Italy, 29100
        • Novartis Investigative Site
    • PD
      • Camposampiero, PD, Italy, 35012
        • Novartis Investigative Site
      • Monselice, PD, Italy, 35043
        • Novartis Investigative Site
      • Padova, PD, Italy, 35128
        • Novartis Investigative Site
      • Padova, PD, Italy, 35100
        • Novartis Investigative Site
    • PE
      • Pescara, PE, Italy, 65124
        • Novartis Investigative Site
    • PG
      • Citta' di Castello, PG, Italy, 06012
        • Novartis Investigative Site
      • Foligno, PG, Italy, 06034
        • Novartis Investigative Site
      • Perugia, PG, Italy, 06100
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RC
      • Reggio Calabria, RC, Italy, 89124
        • Novartis Investigative Site
    • RE
      • Correggio, RE, Italy, 42015
        • Novartis Investigative Site
      • Reggio Emilia, RE, Italy, 42123
        • Novartis Investigative Site
    • RM
      • Civitavecchia, RM, Italy, 00053
        • Novartis Investigative Site
      • Roma, RM, Italy, 00168
        • Novartis Investigative Site
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
      • Roma, RM, Italy, 00133
        • Novartis Investigative Site
      • Roma, RM, Italy, 00184
        • Novartis Investigative Site
      • Roma, RM, Italy, 00189
        • Novartis Investigative Site
      • Roma, RM, Italy, 00186
        • Novartis Investigative Site
    • RN
      • Riccione, RN, Italy, 47838
        • Novartis Investigative Site
    • SA
      • Eboli, SA, Italy, 84025
        • Novartis Investigative Site
      • Salerno, SA, Italy, 84131
        • Novartis Investigative Site
    • SO
      • Sondrio, SO, Italy, 23100
        • Novartis Investigative Site
    • SP
      • Sarzana, SP, Italy, 19038
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italy, 07100
        • Novartis Investigative Site
    • SV
      • Savona, SV, Italy, 17100
        • Novartis Investigative Site
    • TA
      • Taranto, TA, Italy, 74100
        • Novartis Investigative Site
    • TE
      • Teramo, TE, Italy, 64100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10122
        • Novartis Investigative Site
      • Torino, TO, Italy, 10153
        • Novartis Investigative Site
      • Torino, TO, Italy, 10152
        • Novartis Investigative Site
    • TR
      • Terni, TR, Italy, 05100
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italy, 34129
        • Novartis Investigative Site
    • TV
      • Conegliano, TV, Italy, 31015
        • Novartis Investigative Site
      • Treviso, TV, Italy, 31100
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italy, 33100
        • Novartis Investigative Site
    • VA
      • Busto Arsizio, VA, Italy, 21052
        • Novartis Investigative Site
      • Somma Lombardo, VA, Italy, 21019
        • Novartis Investigative Site
      • Varese, VA, Italy, 21100
        • Novartis Investigative Site
    • VI
      • Santorso, VI, Italy, 36014
        • Novartis Investigative Site
      • Vicenza, VI, Italy, 36100
        • Novartis Investigative Site
    • VR
      • Legnago, VR, Italy, 37045
        • Novartis Investigative Site
      • Negrar, VR, Italy, 37024
        • Novartis Investigative Site
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ranibizumab
Administered as an Intravitreal injection
Drug: ranibizumab
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Month 12
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.
Baseline to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Number of Ranibizumab Injections
Time Frame: Baseline to month 12
Baseline to month 12
Time Interval Between Injections in Bilateral Disease
Time Frame: Baseline to month 12
Mean number of days between two consecutive injections per eye
Baseline to month 12
Mean Number of Injections Per Patient
Time Frame: Baseline to month 12
Number of injections per patient
Baseline to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRFB002AIT02
  • 2013-003333-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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