Trial Outcomes & Findings for Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration (NCT NCT01780935)
NCT ID: NCT01780935
Last Updated: 2017-08-14
Results Overview
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
COMPLETED
PHASE3
671 participants
up to Month 12
2017-08-14
Participant Flow
Participant milestones
| Measure |
RBZ 0.5 mg: VA Only (Group I)
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Overall Study
STARTED
|
335
|
336
|
|
Overall Study
Safety Set
|
334
|
336
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
335
|
336
|
Reasons for withdrawal
| Measure |
RBZ 0.5 mg: VA Only (Group I)
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Overall Study
Admin problems due to early termination
|
321
|
309
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Death
|
1
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol deviation
|
0
|
1
|
|
Overall Study
Patient withdrew consent
|
8
|
9
|
Baseline Characteristics
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
RBZ 0.5 mg: VA Only (Group I)
n=335 Participants
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
n=336 Participants
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
Total
n=671 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
75.3 years
STANDARD_DEVIATION 7.91 • n=7 Participants
|
74.6 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Month 12Population: Full Analysis Set (FAS) includes all randomized patients
Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.
Outcome measures
| Measure |
RBZ 0.5 mg: VA Only (Group I)
n=335 Participants
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
n=336 Participants
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12
|
0.1 Letters correctly read
Standard Deviation 6.79
|
1.0 Letters correctly read
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: up to Month 12Population: Full Analysis Set (FAS) includes all randomized patients
Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.
Outcome measures
| Measure |
RBZ 0.5 mg: VA Only (Group I)
n=335 Participants
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
n=336 Participants
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12
|
6.7 letters correctly read
Standard Deviation 13.48
|
8.3 letters correctly read
Standard Deviation 13.53
|
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3 to Month 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening to Month 12 and 24Population: Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
Outcome measures
Outcome data not reported
Adverse Events
RBZ 0.5 mg: VA Only (Group I)
RBZ 0.5 mg: VA and/or OCT (Group II)
Serious adverse events
| Measure |
RBZ 0.5 mg: VA Only (Group I)
n=334 participants at risk
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
n=336 participants at risk
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/334
|
0.30%
1/336
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
1/334
|
0.00%
0/336
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.30%
1/334
|
0.00%
0/336
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/334
|
0.30%
1/336
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.30%
1/334
|
0.00%
0/336
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.30%
1/334
|
0.00%
0/336
|
|
Investigations
Visual acuity tests abnormal (Study eye)
|
0.30%
1/334
|
0.00%
0/336
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/334
|
0.30%
1/336
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/334
|
0.30%
1/336
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
1/334
|
0.00%
0/336
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/334
|
0.30%
1/336
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
1/334
|
0.00%
0/336
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/334
|
0.89%
3/336
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.30%
1/334
|
0.00%
0/336
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/334
|
0.30%
1/336
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/334
|
0.30%
1/336
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/334
|
0.30%
1/336
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.30%
1/334
|
0.00%
0/336
|
|
Eye disorders
Choroidal haemorrhage (Study eye)
|
0.00%
0/334
|
0.30%
1/336
|
|
Eye disorders
Optic ischaemic neuropathy (Fellow untreated eye)
|
0.30%
1/334
|
0.00%
0/336
|
|
Eye disorders
Retinal artery embolism (Study eye)
|
0.00%
0/334
|
0.30%
1/336
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
0.30%
1/334
|
0.30%
1/336
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.30%
1/334
|
0.00%
0/336
|
|
Gastrointestinal disorders
Constipation
|
0.30%
1/334
|
0.00%
0/336
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.30%
1/334
|
0.00%
0/336
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.30%
1/334
|
0.00%
0/336
|
|
General disorders
Death
|
0.00%
0/334
|
0.30%
1/336
|
|
General disorders
Non-cardiac chest pain
|
0.30%
1/334
|
0.00%
0/336
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/334
|
0.30%
1/336
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/334
|
0.30%
1/336
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/334
|
0.30%
1/336
|
|
Infections and infestations
Appendicitis
|
0.30%
1/334
|
0.00%
0/336
|
|
Infections and infestations
Appendicitis perforated
|
0.30%
1/334
|
0.00%
0/336
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/334
|
0.30%
1/336
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/334
|
0.30%
1/336
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
1/334
|
0.60%
2/336
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/334
|
0.30%
1/336
|
|
Infections and infestations
Otitis media chronic
|
0.30%
1/334
|
0.00%
0/336
|
|
Infections and infestations
Pneumonia
|
0.00%
0/334
|
0.89%
3/336
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/334
|
0.30%
1/336
|
|
Infections and infestations
Urosepsis
|
0.30%
1/334
|
0.00%
0/336
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.30%
1/334
|
0.00%
0/336
|
|
Injury, poisoning and procedural complications
Concussion
|
0.30%
1/334
|
0.30%
1/336
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/334
|
0.30%
1/336
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/334
|
0.30%
1/336
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/334
|
1.2%
4/336
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
2/334
|
0.30%
1/336
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/334
|
0.30%
1/336
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.30%
1/334
|
0.00%
0/336
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.30%
1/334
|
0.00%
0/336
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.30%
1/334
|
0.00%
0/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/334
|
0.30%
1/336
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Carotid artery occlusion
|
0.30%
1/334
|
0.00%
0/336
|
|
Nervous system disorders
Carotid artery stenosis
|
0.30%
1/334
|
0.00%
0/336
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
1/334
|
0.00%
0/336
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Encephalitis post varicella (Study eye)
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Presyncope
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Sciatica
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Syncope
|
0.60%
2/334
|
0.00%
0/336
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/334
|
0.30%
1/336
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.30%
1/334
|
0.00%
0/336
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/334
|
0.30%
1/336
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/334
|
0.00%
0/336
|
|
Renal and urinary disorders
Urinary retention
|
0.30%
1/334
|
0.00%
0/336
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.30%
1/334
|
0.00%
0/336
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/334
|
0.60%
2/336
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.30%
1/334
|
0.00%
0/336
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.30%
1/334
|
0.30%
1/336
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/334
|
0.30%
1/336
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/334
|
0.30%
1/336
|
|
Vascular disorders
Hypertension
|
0.00%
0/334
|
0.60%
2/336
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/334
|
0.30%
1/336
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/334
|
0.30%
1/336
|
Other adverse events
| Measure |
RBZ 0.5 mg: VA Only (Group I)
n=334 participants at risk
RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
|
RBZ 0.5 mg: VA and/or OCT (Group II)
n=336 participants at risk
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
|
|---|---|---|
|
Eye disorders
Vitreous floaters (Study eye)
|
1.8%
6/334
|
2.4%
8/336
|
|
Infections and infestations
Bronchitis
|
2.1%
7/334
|
1.8%
6/336
|
|
Eye disorders
Choroidal neovascularisation (Fellow untreated eye)
|
1.5%
5/334
|
2.1%
7/336
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
5.7%
19/334
|
3.0%
10/336
|
|
Eye disorders
Dry eye (Fellow untreated eye)
|
2.1%
7/334
|
1.2%
4/336
|
|
Eye disorders
Dry eye (Study eye)
|
3.0%
10/334
|
2.1%
7/336
|
|
Eye disorders
Eye pain (Study eye)
|
3.0%
10/334
|
2.7%
9/336
|
|
Eye disorders
Neovascular age-related macular degeneration (Fellow untreated eye)
|
2.1%
7/334
|
2.1%
7/336
|
|
Infections and infestations
Influenza
|
4.5%
15/334
|
4.5%
15/336
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
24/334
|
3.3%
11/336
|
|
Infections and infestations
Urinary tract infection
|
0.60%
2/334
|
2.1%
7/336
|
|
Investigations
Intraocular pressure increased (Study eye)
|
3.6%
12/334
|
6.2%
21/336
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
7/334
|
1.5%
5/336
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/334
|
3.0%
10/336
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
7/334
|
2.1%
7/336
|
|
Vascular disorders
Hypertension
|
5.4%
18/334
|
4.5%
15/336
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER