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

Wet Age Related Macular Degeneration Clinical Trial

— TWEYES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986907
• Other study ID #: CRFB002AIT02
• Secondary ID: 2013-003333-15
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2014
• Est. completion date: June 15, 2016

Study information

• Verified date: May 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1049
• Est. completion date: June 15, 2016
• Est. primary completion date: June 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age Related Macular Degeneration

Intervention

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).

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Acireale	CT
Italy	Novartis Investigative Site	Acquaviva delle Fonti	BA
Italy	Novartis Investigative Site	Alessandria	AL
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Belluno	BL
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Bolzano	BZ
Italy	Novartis Investigative Site	Borgomanero
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Busto Arsizio	VA
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Camposampiero	PD
Italy	Novartis Investigative Site	Casale Monferrato	AL
Italy	Novartis Investigative Site	Caserta	CE
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Catanzaro	CZ
Italy	Novartis Investigative Site	Ceva	CN
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Cinisello Balsamo	MI
Italy	Novartis Investigative Site	Citta' di Castello	PG
Italy	Novartis Investigative Site	Civitavecchia	RM
Italy	Novartis Investigative Site	Como	CO
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Conegliano	TV
Italy	Novartis Investigative Site	Correggio	RE
Italy	Novartis Investigative Site	Crotone	KR
Italy	Novartis Investigative Site	Cuneo	CN
Italy	Novartis Investigative Site	Desenzano del Garda	BS
Italy	Novartis Investigative Site	Eboli	SA
Italy	Novartis Investigative Site	Foggia	FG
Italy	Novartis Investigative Site	Foligno	PG
Italy	Novartis Investigative Site	Forlì	FC
Italy	Novartis Investigative Site	Galliate
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Larino	CB
Italy	Novartis Investigative Site	Legnago	VR
Italy	Novartis Investigative Site	Legnano	MI
Italy	Novartis Investigative Site	Messina	ME
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milazzo	ME
Italy	Novartis Investigative Site	Monselice	PD
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Negrar	VR
Italy	Novartis Investigative Site	Nuoro	NU
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Perugia	PG
Italy	Novartis Investigative Site	Pescara	PE
Italy	Novartis Investigative Site	Piacenza	PC
Italy	Novartis Investigative Site	Pordenone	PN
Italy	Novartis Investigative Site	Pozzuoli
Italy	Novartis Investigative Site	Putignano	BA
Italy	Novartis Investigative Site	Rapallo	GE
Italy	Novartis Investigative Site	Reggio Calabria	RC
Italy	Novartis Investigative Site	Reggio Emilia	RE
Italy	Novartis Investigative Site	Riccione	RN
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Salerno	SA
Italy	Novartis Investigative Site	San Feramo Della Battaglia	CO
Italy	Novartis Investigative Site	San Giovanni Rotondo	FG
Italy	Novartis Investigative Site	Santorso	VI
Italy	Novartis Investigative Site	Sarzana	SP
Italy	Novartis Investigative Site	Sassari	SS
Italy	Novartis Investigative Site	Savona	SV
Italy	Novartis Investigative Site	Somma Lombardo	VA
Italy	Novartis Investigative Site	Sondrio	SO
Italy	Novartis Investigative Site	Taranto	TA
Italy	Novartis Investigative Site	Teramo	TE
Italy	Novartis Investigative Site	Terlizzi	BA
Italy	Novartis Investigative Site	Terni	TR
Italy	Novartis Investigative Site	Terracina	LT
Italy	Novartis Investigative Site	Torino	TO
Italy	Novartis Investigative Site	Torino	TO
Italy	Novartis Investigative Site	Torino	TO
Italy	Novartis Investigative Site	Treviso	TV
Italy	Novartis Investigative Site	Tricase	LE
Italy	Novartis Investigative Site	Trieste	TS
Italy	Novartis Investigative Site	Udine	UD
Italy	Novartis Investigative Site	Varese	VA
Italy	Novartis Investigative Site	Verona	VR
Italy	Novartis Investigative Site	Vicenza	VI
Italy	Novartis Investigative Site	Vizzolo Predabissi	MI

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Systemic Drug-related Adverse Events	Monitoring and recording all adverse events, including serious adverse events.	Baseline to Month 12
Primary	Number of Eyes With Ocular Drug-related Adverse Events	Monitoring and recording all adverse events, including serious adverse events.	Baseline to Month 12
Secondary	Overall Number of Ranibizumab Injections		Baseline to month 12
Secondary	Time Interval Between Injections in Bilateral Disease	Mean number of days between two consecutive injections per eye	Baseline to month 12
Secondary	Mean Number of Injections Per Patient	Number of injections per patient	Baseline to month 12

External Links

•   Novartis Trial Results