Clinical trial NCT01846299: To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
Official title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema (ME)
Keywords: Vision Impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 181
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: To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
* BCVA must be between ≥ 24 and ≤ 83 letters;
* Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion Criteria:

* Women of child-bearing potential,
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* Any type of advanced, severe or unstable ocular disease or its reatment;
* ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
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: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline
timeFrame: Month 2, Month 6, Month 12
measure: Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline
timeFrame: Month 2, Month 6, Month 12
measure: Number of Participants With Presence of Active Macular Edema (ME) Leakage
timeFrame: Month 2
measure: Number of Participants Requiring Rescue Treatment at Month 1
timeFrame: Month 1
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 Ranibizumab Treatments
timeFrame: Month 12
measure: Number of Participants With Re-treatments
timeFrame: Month 6, month 12
measure: Number of Primary Reasons for Decision to Treat by Investigator
timeFrame: 12 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: South Launceston
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Plzen
country: Czech Republic
facility: Novartis Investigative Site
city: Praha 10
country: Czech Republic
facility: Novartis Investigative Site
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Saint-Jean
country: France
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: Regensburg
country: Germany
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: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar-Sava
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
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: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Tilburg
country: Netherlands
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: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
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: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: