Clinical trial NCT01986907: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wet Age Related Macular Degeneration
Keywords: wet AMD
macular degeneration
ranibizumab
mono-bilateral
poor visual acuity
retinal disease
eye disease
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 1049
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Systemic Drug-related Adverse Events
timeFrame: Baseline to Month 12
measure: Number of Eyes With Ocular Drug-related Adverse Events
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Overall Number of Ranibizumab Injections
timeFrame: Baseline to month 12
measure: Time Interval Between Injections in Bilateral Disease
timeFrame: Baseline to month 12
measure: Mean Number of Injections Per Patient
timeFrame: Baseline to month 12
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Novartis Investigative Site
state: AL
city: Casale Monferrato
country: Italy
facility: Novartis Investigative Site
state: AL
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Acquaviva delle Fonti
country: Italy
facility: Novartis Investigative Site
state: BA
city: Putignano
country: Italy
facility: Novartis Investigative Site
state: BA
city: Terlizzi
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Belluno
country: Italy
facility: Novartis Investigative Site
state: BL
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Desenzano del Garda
country: Italy
facility: Novartis Investigative Site
state: BS
city: Bolzano
country: Italy
facility: Novartis Investigative Site
state: BZ
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Larino
country: Italy
facility: Novartis Investigative Site
state: CB
city: Caserta
country: Italy
facility: Novartis Investigative Site
state: CE
city: Chieti
country: Italy
facility: Novartis Investigative Site
state: CH
city: Ceva
country: Italy
facility: Novartis Investigative Site
state: CN
city: Cuneo
country: Italy
facility: Novartis Investigative Site
state: CN
city: Como
country: Italy
facility: Novartis Investigative Site
state: CO
city: San Feramo Della Battaglia
country: Italy
facility: Novartis Investigative Site
state: CO
city: Acireale
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Forlì
country: Italy
facility: Novartis Investigative Site
state: FC
city: Cona
country: Italy
facility: Novartis Investigative Site
state: FE
city: Foggia
country: Italy
facility: Novartis Investigative Site
state: FG
city: San Giovanni Rotondo
country: Italy
facility: Novartis Investigative Site
state: FG
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Rapallo
country: Italy
facility: Novartis Investigative Site
state: GE
city: Crotone
country: Italy
facility: Novartis Investigative Site
state: KR
city: Tricase
country: Italy
facility: Novartis Investigative Site
state: LE
city: Terracina
country: Italy
facility: Novartis Investigative Site
state: LT
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milazzo
country: Italy
facility: Novartis Investigative Site
state: ME
city: Cinisello Balsamo
country: Italy
facility: Novartis Investigative Site
state: MI
city: Legnano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Vizzolo Predabissi
country: Italy
facility: Novartis Investigative Site
state: MI
city: Nuoro
country: Italy
facility: Novartis Investigative Site
state: NU
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Piacenza
country: Italy
facility: Novartis Investigative Site
state: PC
city: Camposampiero
country: Italy
facility: Novartis Investigative Site
state: PD
city: Monselice
country: Italy
facility: Novartis Investigative Site
state: PD
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pescara
country: Italy
facility: Novartis Investigative Site
state: PE
city: Citta' di Castello
country: Italy
facility: Novartis Investigative Site
state: PG
city: Foligno
country: Italy
facility: Novartis Investigative Site
state: PG
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: PN
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Reggio Calabria
country: Italy
facility: Novartis Investigative Site
state: RC
city: Correggio
country: Italy
facility: Novartis Investigative Site
state: RE
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Civitavecchia
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Riccione
country: Italy
facility: Novartis Investigative Site
state: RN
city: Eboli
country: Italy
facility: Novartis Investigative Site
state: SA
city: Salerno
country: Italy
facility: Novartis Investigative Site
state: SA
city: Sondrio
country: Italy
facility: Novartis Investigative Site
state: SO
city: Sarzana
country: Italy
facility: Novartis Investigative Site
state: SP
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Savona
country: Italy
facility: Novartis Investigative Site
state: SV
city: Taranto
country: Italy
facility: Novartis Investigative Site
state: TA
city: Teramo
country: Italy
facility: Novartis Investigative Site
state: TE
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Terni
country: Italy
facility: Novartis Investigative Site
state: TR
city: Trieste
country: Italy
facility: Novartis Investigative Site
state: TS
city: Conegliano
country: Italy
facility: Novartis Investigative Site
state: TV
city: Treviso
country: Italy
facility: Novartis Investigative Site
state: TV
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Busto Arsizio
country: Italy
facility: Novartis Investigative Site
state: VA
city: Somma Lombardo
country: Italy
facility: Novartis Investigative Site
state: VA
city: Varese
country: Italy
facility: Novartis Investigative Site
state: VA
city: Santorso
country: Italy
facility: Novartis Investigative Site
state: VI
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Legnago
country: Italy
facility: Novartis Investigative Site
state: VR
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Borgomanero
country: Italy
facility: Novartis Investigative Site
city: Galliate
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Pozzuoli
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: