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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

NCT ID: NCT01986907

Last Updated: 2019-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-04

Study Completion Date

2016-06-15

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

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Detailed Description

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Conditions

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Wet Age Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab

Administered as an Intravitreal injection

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Alessandria, AL, Italy

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Novartis Investigative Site

Casale Monferrato, AL, Italy

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Ancona, AN, Italy

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Acquaviva delle Fonti, BA, Italy

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Putignano, BA, Italy

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Terlizzi, BA, Italy

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Bergamo, BG, Italy

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Belluno, BL, Italy

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Bologna, BO, Italy

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Brescia, BS, Italy

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Desenzano del Garda, BS, Italy

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Bolzano, BZ, Italy

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Cagliari, CA, Italy

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Larino, CB, Italy

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Caserta, CE, Italy

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Chieti, CH, Italy

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Ceva, CN, Italy

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Cuneo, CN, Italy

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Como, CO, Italy

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San Feramo Della Battaglia, CO, Italy

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Acireale, CT, Italy

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Catania, CT, Italy

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Catania, CT, Italy

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Catanzaro, CZ, Italy

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Forlì, FC, Italy

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Cona, FE, Italy

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Foggia, FG, Italy

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San Giovanni Rotondo, FG, Italy

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Genova, GE, Italy

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Genova, GE, Italy

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Rapallo, GE, Italy

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Crotone, KR, Italy

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Tricase, LE, Italy

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Terracina, LT, Italy

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Messina, ME, Italy

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Milazzo, ME, Italy

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Cinisello Balsamo, MI, Italy

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Legnano, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Vizzolo Predabissi, MI, Italy

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Nuoro, NU, Italy

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Palermo, PA, Italy

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Palermo, PA, Italy

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Piacenza, PC, Italy

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Camposampiero, PD, Italy

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Monselice, PD, Italy

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Padua, PD, Italy

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Padua, PD, Italy

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Pescara, PE, Italy

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Città di Castello, PG, Italy

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Foligno, PG, Italy

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Perugia, PG, Italy

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Pordenone, PN, Italy

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Parma, PR, Italy

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Pavia, PV, Italy

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Reggio Calabria, RC, Italy

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Correggio, RE, Italy

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Reggio Emilia, RE, Italy

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Civitavecchia, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Riccione, RN, Italy

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Eboli, SA, Italy

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Salerno, SA, Italy

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Sondrio, SO, Italy

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Sarzana, SP, Italy

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Sassari, SS, Italy

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Savona, SV, Italy

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Taranto, TA, Italy

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Teramo, TE, Italy

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Torino, TO, Italy

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Torino, TO, Italy

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Torino, TO, Italy

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Terni, TR, Italy

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Trieste, TS, Italy

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Conegliano, TV, Italy

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Treviso, TV, Italy

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Udine, UD, Italy

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Busto Arsizio, VA, Italy

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Somma Lombardo, VA, Italy

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Varese, VA, Italy

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Santorso, VI, Italy

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Vicenza, VI, Italy

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Legnago, VR, Italy

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Negrar, VR, Italy

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Verona, VR, Italy

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Borgomanero, , Italy

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Galliate, , Italy

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Napoli, , Italy

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Napoli, , Italy

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Napoli, , Italy

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Pozzuoli, , Italy

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Countries

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Italy

Other Identifiers

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2013-003333-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002AIT02

Identifier Type: -

Identifier Source: org_study_id

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