Clinical trial NCT01840410: Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
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 Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choroidal Neovascularization (CNV)
Keywords: Vision Impairment
Abnormal growth of blood vessels
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 183
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).


Eligibility criteria: Key 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;

Key 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.

Primary outcomes:
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
timeFrame: Baseline, Month 2
Secondary outcomes:
measure: Change From Baseline in BCVA in Study Eye up to Month 2
timeFrame: Baseline, Month 1, Month 2
measure: Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
timeFrame: Baseline, Month 2, Month 6, Month 12
measure: Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
timeFrame: Baseline, Month 2, Month 6, Month 12
measure: Number of Participants With Presence of Active Chorioretinal Leakage
timeFrame: Baseline, Month 2, Month 6, Month 12
measure: Average Change From Baseline in BCVA
timeFrame: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
measure: Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
timeFrame: Month 2, Month 6, Month 12
measure: Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
timeFrame: Month 2, Month 6, Month 12
measure: Number of Participants With Requirement for Rescue Treatment at Month 1
timeFrame: Month 1
measure: Number of Participants With Ranibizumab Treatments in Study Eye
timeFrame: Month 12
measure: Number of Participants With Re-treatments
timeFrame: Month 12
measure: Number of Primary Reasons for Decision to Treat by Investigator
timeFrame: Month 12
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: South Launceston
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 10
country: Czech Republic
facility: Novartis Investigative Site
city: Glostrup
country: Denmark
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Paris, Cedex 12
country: France
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Freiburg i. Br
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Heraklion Crete
country: Greece
facility: Novartis Investigative Site
state: GR
city: Patras
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Varese
country: Italy
facility: Novartis Investigative Site
state: VA
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Coimbra
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Trencin
country: Slovakia
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Sant Cugat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Binningen
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: