Assess the Efficacy/Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Choroidal Neovascularization.

Choroidal Neovascularization (CNV) Clinical Trial

Official title:

A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to VEGF-driven Choroidal Neovascularization.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840410
• Other study ID #: CRFB002G2301
• Secondary ID: 2012-005417-38
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2013
• Last updated: March 2, 2016
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to choridal neovascularization (CNV).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;

• BCVA must be between = 24 and = 83 letters in the study eye;

• Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV.

Exclusion Criteria:

• Women of child-bearing potential;

• Active malignancies;

• History of stroke less than 6 months prior to screening;

• Uncontrolled systemic inflammation or infection;

• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;

• CNV- conditions with a high likelihood of spontaneous resolution;

• History of intravitreal treatment with steroids;

• History of laser photocoagulation;

• History of intraocular treatment with any anti-angiogenic drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Choroidal Neovascularization (CNV)
• Neovascularization, Pathologic

Intervention

Drug:
• Ranibizumab
Ranibizumab 0.5 mg is administered intravitreally to the patient

Other:
• Sham control
The sham vial will not contain active drug (empty sterile vial). The sham injection is an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	South Launceston	Tasmania
Australia	Novartis Investigative Site	Sydney	New South Wales
Canada	Novartis Investigative Site	Montreal	Quebec
Czech Republic	Novartis Investigative Site	Hradec Kralove
Czech Republic	Novartis Investigative Site	Praha 10
Denmark	Novartis Investigative Site	Glostrup
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Paris, Cedex 12
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Freiburg i. Br
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Tübingen
Greece	Novartis Investigative Site	Heraklion Crete	GR
Greece	Novartis Investigative Site	Patras
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Szeged
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Udine	UD
Italy	Novartis Investigative Site	Varese	VA
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Vilnius
Peru	Novartis Investigative Site	San Isidro	Lima
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Porto
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Trencin
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Sant Cugat	Catalunya
Spain	Novartis Investigative Site	Valladolid	Castilla y Leon
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Binningen
Switzerland	Novartis Investigative Site	Lausanne
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Peru,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye	The change in BCVA from baseline to Month 2	Baseline and Month 2	No
Secondary	BCVA change from baseline by visit up to Month 2 in study eye (ranibizumab as compared to sham treatment)	The change in BCVA will be presented by each visit (BSL, Month 1, Month 2)	Baseline, Month 2	No
Secondary	Change in central subfield thickness (CSFT) and central subfield volume (CSFV) in study eye from baseline over time to Month 2	CSFT and CSFV will be assessed by optical coherence tomography (OCT).	Baseline, Month 2	No
Secondary	Presence of intra-/sub-retinal fluid in study eye at Month 2	The presence of intra-/sub-retinal fluid will be assessed by OCT images.	Baseline, Month 2	No
Secondary	Presence of active chorioretinal leakage assessed by FA at Month 2	The presence of active chorioretinal leakage will be assessed by photography imaging (i.e.FA).	Month 2	No
Secondary	Average BCVA change in study eye from baseline to Month 1 through Month 12	All monthly BCVA outcomes compared to the BCVA at baseline.	Baseline, Month 1, Month 6, Month 12	No
Secondary	Change from baseline in CSFT and CSFV in study eye by visit	The change in CSFT and CSFV will be assessed monthly by OCT	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12	No
Secondary	Presence of intra-/subretinal fluid in study eye at Month 2, Month 6 and Month 12 compared to Baseline	The presence of intra-/sub-retinal fluid will be assessed by OCT	Baseline, Month 2, Month 6, Month 12	No
Secondary	Presence of active chorioretinal leakage in study eye at Month 2, Month 6 and Month 12 compared to Baseline	The presence of active chorioretinal leakage will be assessed by photographic images (i.e., FA).	Baseline, Month 2, Month 6, Month 12	No
Secondary	Proportion of patients with = 1, = 5, = 10 and = 15 letters gain or reaching 84 letters in study eye, at Month 2, Month 6 and Month 12	This outcome measure represents the proportion of different levels of BCVA gain	Month 2, Month 6, Month 12	No
Secondary	Proportion of patients with > 1, > 5, > 10 and > 15 letters loss at Month 2, Month 6 and Month 12	This outcome measure represents the proportion of different levels of BCVA loss.	Month 2, Month 6, Month 12	No
Secondary	Number of ranibizumab treatments and re-treatments to study eye by Month 2, Month 6 and Month 12	Total number of injections and number of injections given to the study eye by visit	Month 2, Month 6, Month 12	No
Secondary	Type, frequency and severity of ocular and non-ocular adverse events in the study eye up to Month 2, up to Month 6 and up to Month 12	Safety parameters will include reports of both ocular and non-ocular adverse events (AEs). Safety findings resulting from ophthalmic examinations, vital signs, and laboratory results if reported as an adverse event (AE) will be presented.	Month 2, Month 6, Month 12	Yes
Secondary	Requirement for rescue treatment at Month 1		Month 1	No