Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331864
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : January 4, 2011
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Age Related Macular Degeneration
Choroidal Neovascularization
Intervention Drug: Ranibizumab
Enrollment 531
Recruitment Details The study population consisted of two groups, one group being naïve to ranibizumab ("Non-ANCHOR" patients) and the other group were those patients who previously were treated with ranibizumab in the ANCHOR study (NCT00061594; "ANCHOR" patients).
Pre-assignment Details  
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment. Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Period Title: Overall Study
Started 513 18
Completed 455 14
Not Completed 58 4
Reason Not Completed
Adverse Event             30             1
Lack of Efficacy             4             0
Protocol Violation             3             0
Withdrawal by Subject             10             0
Lost to Follow-up             4             3
Administrative Problems             1             0
Death             6             0
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR Total
Hide Arm/Group Description Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment. Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment. Total of all reporting groups
Overall Number of Baseline Participants 513 18 531
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 513 participants 18 participants 531 participants
< 50 years 1 0 1
50 to < 65 years 49 0 49
65 to < 75 years 173 5 178
75 to < 85 years 230 12 242
≥ 85 years 60 1 61
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 513 participants 18 participants 531 participants
Female
294
  57.3%
9
  50.0%
303
  57.1%
Male
219
  42.7%
9
  50.0%
228
  42.9%
1.Primary Outcome
Title Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
Hide Description Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Time Frame Baseline through end of study (12 month treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 513 18
Measure Type: Number
Unit of Measure: Percentage of Participants
48.5 38.9
2.Primary Outcome
Title Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
Hide Description

Grade 3 targeted AEs included:

  • 4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days
  • ≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection
  • sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days
  • new retinal tear or detachment involving the macula
  • new vitreous hemorrhage >2+ severity not resolving within 14 days
  • new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea
Time Frame Baseline through end of study (12 month treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 513 18
Measure Type: Number
Unit of Measure: Percentage of Participants
2.9 0.0
3.Secondary Outcome
Title Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
Hide Description

BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.

BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.

Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 509 15
Mean (Standard Deviation)
Unit of Measure: Letters on the ETDRS-like testing charts
Baseline 56.2  (12.11) 47.2  (22.10)
Change to Month 3 5.8  (11.12) 1.9  (9.26)
4.Secondary Outcome
Title Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
Hide Description

BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.

BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.

Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 509 17
Mean (Standard Deviation)
Unit of Measure: Letters on the ETDRS-like testing charts
Baseline 56.2  (12.11) 47.2  (22.10)
Change to Month 12 3.6  (13.89) 1.6  (8.66)
5.Secondary Outcome
Title Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
Hide Description Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 507 15
Mean (Standard Deviation)
Unit of Measure: Micrometers
Baseline 339.6  (109.38) 214.1  (64.92)
Change to Month 3 -101.1  (115.69) 36.3  (72.96)
6.Secondary Outcome
Title Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
Hide Description Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 507 17
Mean (Standard Deviation)
Unit of Measure: Micrometers
Baseline 339.6  (109.38) 214.1  (64.92)
Change to Month 12 -91.5  (115.47) 39.3  (84.61)
7.Secondary Outcome
Title Time to the First Retreatment After Month 2
Hide Description

Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.

Criteria for re-treatment:

  • a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)
  • a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)
Time Frame Month 2 to Month 11
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.
Arm/Group Title Ranibizumab Non-ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 500
Median (Inter-Quartile Range)
Unit of Measure: Months
2
(1 to 6)
8.Secondary Outcome
Title Total Number of Treatments
Hide Description Total number of treatments administered during the entire treatment period (Month 0 to 11).
Time Frame Baseline (Month 0) to Month 11
Hide Outcome Measure Data
Hide Analysis Population Description
For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description:
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
Overall Number of Participants Analyzed 513 18
Mean (Standard Deviation)
Unit of Measure: Treatments
5.6  (2.37) 1.1  (2.29)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Hide Arm/Group Description Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment. Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
All-Cause Mortality
Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Affected / at Risk (%) Affected / at Risk (%)
Total   80/513 (15.59%)   4/18 (22.22%) 
Blood and lymphatic system disorders     
Anaemia  1  1/513 (0.19%)  1/18 (5.56%) 
Cardiac disorders     
Acute coronary syndrome  1  1/513 (0.19%)  0/18 (0.00%) 
Acute myocardial infarction  1  1/513 (0.19%)  1/18 (5.56%) 
Angina pectoris  1  3/513 (0.58%)  0/18 (0.00%) 
Arrhythmia  1  3/513 (0.58%)  0/18 (0.00%) 
Atrial fibrillation  1  2/513 (0.39%)  1/18 (5.56%) 
Cardiac failure  1  6/513 (1.17%)  0/18 (0.00%) 
Cardiogenic shock  1  1/513 (0.19%)  0/18 (0.00%) 
Coronary artery disease  1  1/513 (0.19%)  0/18 (0.00%) 
Intracardiac thrombus  1  1/513 (0.19%)  0/18 (0.00%) 
Myocardial infarction  1  5/513 (0.97%)  0/18 (0.00%) 
Myocardial ischaemia  1  1/513 (0.19%)  0/18 (0.00%) 
Silent myocardial infarction  1  1/513 (0.19%)  0/18 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/513 (0.19%)  0/18 (0.00%) 
Vestibular disorder  1  1/513 (0.19%)  0/18 (0.00%) 
Eye disorders     
Cataract (Fellow eye)  1  3/513 (0.58%)  0/18 (0.00%) 
Cataract (Study eye)  1  1/513 (0.19%)  0/18 (0.00%) 
Choroidal neovascularisation (Fellow eye)  1  1/513 (0.19%)  0/18 (0.00%) 
Retinal haemorrhage (Study eye)  1  2/513 (0.39%)  0/18 (0.00%) 
Retinal pigment epithelial tear (Study eye)  1  1/513 (0.19%)  0/18 (0.00%) 
Visual acuity reduced (Study eye)  1  1/513 (0.19%)  0/18 (0.00%) 
Vitreous haemorrhage (Study eye)  1  1/513 (0.19%)  0/18 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/513 (0.19%)  0/18 (0.00%) 
Duodenal ulcer  1  1/513 (0.19%)  0/18 (0.00%) 
Gastric haemorrhage  1  1/513 (0.19%)  0/18 (0.00%) 
Gastric ulcer haemorrhage  1  1/513 (0.19%)  0/18 (0.00%) 
Gastritis erosive  1  1/513 (0.19%)  0/18 (0.00%) 
Haematemesis  1  1/513 (0.19%)  0/18 (0.00%) 
Hiatus hernia  1  1/513 (0.19%)  0/18 (0.00%) 
Intestinal obstruction  1  2/513 (0.39%)  0/18 (0.00%) 
Pancreatitis  1  1/513 (0.19%)  0/18 (0.00%) 
General disorders     
Asthenia  1  2/513 (0.39%)  0/18 (0.00%) 
Chest pain  1  1/513 (0.19%)  0/18 (0.00%) 
Death  1  1/513 (0.19%)  0/18 (0.00%) 
Infections and infestations     
Bronchitis  1  2/513 (0.39%)  0/18 (0.00%) 
Bronchopneumonia  1  1/513 (0.19%)  0/18 (0.00%) 
Clostridium difficile colitis  1  1/513 (0.19%)  0/18 (0.00%) 
Gangrene  1  1/513 (0.19%)  0/18 (0.00%) 
Infected skin ulcer  1  1/513 (0.19%)  0/18 (0.00%) 
Pneumonia  1  2/513 (0.39%)  0/18 (0.00%) 
Respiratory tract infection  1  1/513 (0.19%)  0/18 (0.00%) 
Sepsis  1  2/513 (0.39%)  0/18 (0.00%) 
Urinary tract infection  1  1/513 (0.19%)  0/18 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/513 (0.19%)  0/18 (0.00%) 
Fall  1  0/513 (0.00%)  1/18 (5.56%) 
Femur fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Hip fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Humerus fracture  1  0/513 (0.00%)  1/18 (5.56%) 
Joint injury  1  1/513 (0.19%)  0/18 (0.00%) 
Limb injury  1  1/513 (0.19%)  0/18 (0.00%) 
Lumbar vertebral fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Pelvic fracture  1  0/513 (0.00%)  1/18 (5.56%) 
Rib fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Road traffic accident  1  1/513 (0.19%)  0/18 (0.00%) 
Skeletal injury  1  1/513 (0.19%)  0/18 (0.00%) 
Upper limb fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Wrist fracture  1  1/513 (0.19%)  0/18 (0.00%) 
Investigations     
Blood urine present  1  1/513 (0.19%)  0/18 (0.00%) 
Cardioactive drug level increased  1  1/513 (0.19%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/513 (0.19%)  0/18 (0.00%) 
Diabetes mellitus inadequate control  1  1/513 (0.19%)  0/18 (0.00%) 
Metabolic acidosis  1  1/513 (0.19%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/513 (0.78%)  0/18 (0.00%) 
Mobility decreased  1  1/513 (0.19%)  0/18 (0.00%) 
Musculoskeletal chest pain  1  1/513 (0.19%)  0/18 (0.00%) 
Osteoporosis  1  1/513 (0.19%)  0/18 (0.00%) 
Pain in extremity  1  1/513 (0.19%)  0/18 (0.00%) 
Spinal column stenosis  1  1/513 (0.19%)  0/18 (0.00%) 
Spinal osteoarthritis  1  1/513 (0.19%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma  1  1/513 (0.19%)  0/18 (0.00%) 
Bladder cancer  1  2/513 (0.39%)  0/18 (0.00%) 
Breast cancer  1  3/513 (0.58%)  0/18 (0.00%) 
Colon adenoma  1  1/513 (0.19%)  0/18 (0.00%) 
Colon cancer  1  3/513 (0.58%)  0/18 (0.00%) 
Extranodal marginal zone B-cell lymphoma (MALT type)  1  0/513 (0.00%)  1/18 (5.56%) 
Gastrointestinal neoplasm  1  1/513 (0.19%)  0/18 (0.00%) 
Laryngeal neoplasm  1  1/513 (0.19%)  0/18 (0.00%) 
Lymphoma  1  1/513 (0.19%)  0/18 (0.00%) 
Metastases to lung  1  1/513 (0.19%)  0/18 (0.00%) 
Metastatic neoplasm  1  1/513 (0.19%)  0/18 (0.00%) 
Myelodysplastic syndrome  1  2/513 (0.39%)  0/18 (0.00%) 
Neuroma  1  1/513 (0.19%)  0/18 (0.00%) 
Prostate cancer  1  2/513 (0.39%)  0/18 (0.00%) 
Prostate cancer metastatic  1  1/513 (0.19%)  0/18 (0.00%) 
Renal cell carcinoma  1  1/513 (0.19%)  0/18 (0.00%) 
Renal neoplasm  1  1/513 (0.19%)  0/18 (0.00%) 
Thyroid cancer  1  1/513 (0.19%)  0/18 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/513 (0.19%)  0/18 (0.00%) 
Cerebrovascular accident  1  1/513 (0.19%)  1/18 (5.56%) 
Diabetic coma  1  1/513 (0.19%)  0/18 (0.00%) 
Dizziness  1  1/513 (0.19%)  0/18 (0.00%) 
Hypoaesthesia  1  0/513 (0.00%)  1/18 (5.56%) 
Presyncope  1  1/513 (0.19%)  0/18 (0.00%) 
Sciatica  1  1/513 (0.19%)  0/18 (0.00%) 
Syncope  1  1/513 (0.19%)  0/18 (0.00%) 
Transient ischaemic attack  1  2/513 (0.39%)  0/18 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/513 (0.19%)  0/18 (0.00%) 
Renal failure acute  1  1/513 (0.19%)  0/18 (0.00%) 
Renal failure chronic  1  1/513 (0.19%)  0/18 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/513 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/513 (0.19%)  0/18 (0.00%) 
Chronic obstructive pulmonary disease  1  1/513 (0.19%)  0/18 (0.00%) 
Dyspnoea  1  2/513 (0.39%)  0/18 (0.00%) 
Lung disorder  1  1/513 (0.19%)  0/18 (0.00%) 
Pleural effusion  1  1/513 (0.19%)  0/18 (0.00%) 
Pulmonary embolism  1  2/513 (0.39%)  0/18 (0.00%) 
Pulmonary oedema  1  1/513 (0.19%)  0/18 (0.00%) 
Respiratory failure  1  1/513 (0.19%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  1/513 (0.19%)  0/18 (0.00%) 
Vascular disorders     
Aortic aneurysm rupture  1  1/513 (0.19%)  0/18 (0.00%) 
Arteriosclerosis  1  1/513 (0.19%)  0/18 (0.00%) 
Circulatory collapse  1  2/513 (0.39%)  0/18 (0.00%) 
Deep vein thrombosis  1  1/513 (0.19%)  0/18 (0.00%) 
Hypertension  1  2/513 (0.39%)  0/18 (0.00%) 
Hypotension  1  1/513 (0.19%)  0/18 (0.00%) 
Peripheral embolism  1  1/513 (0.19%)  0/18 (0.00%) 
Poor peripheral circulation  1  1/513 (0.19%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ranibizumab Non-ANCHOR Ranibizumab ANCHOR
Affected / at Risk (%) Affected / at Risk (%)
Total   199/513 (38.79%)   8/18 (44.44%) 
Eye disorders     
Choroidal neovascularisation (Fellow eye)  1  16/513 (3.12%)  2/18 (11.11%) 
Choroidal neovascularisation (Study eye)  1  8/513 (1.56%)  2/18 (11.11%) 
Conjunctival haemorrhage (Study eye)  1  28/513 (5.46%)  0/18 (0.00%) 
Retinal haemorrhage (Fellow eye)  1  12/513 (2.34%)  2/18 (11.11%) 
Retinal haemorrhage (Study eye)  1  35/513 (6.82%)  5/18 (27.78%) 
Retinal oedema (Study eye)  1  8/513 (1.56%)  2/18 (11.11%) 
Visual acuity reduced (Fellow eye)  1  23/513 (4.48%)  1/18 (5.56%) 
Visual acuity reduced (Study eye)  1  94/513 (18.32%)  1/18 (5.56%) 
Investigations     
Intraocular pressure increased (Study eye)  1  36/513 (7.02%)  0/18 (0.00%) 
Nervous system disorders     
Headache  1  13/513 (2.53%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00331864    
Other Study ID Numbers: CRFB002A2303
First Submitted: April 11, 2006
First Posted: May 31, 2006
Results First Submitted: December 9, 2010
Results First Posted: January 4, 2011
Last Update Posted: February 18, 2011