Safety & Efficacy Study Evaluating the Combination of Bev... | NCT00499590

NCT00499590

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Lucentis® (0.5mg) every 4 weeks.	Drug: ranibizumab
B	Experimental	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.	Drug: bevasiranib
C	Experimental	Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.	Drug: bevasiranib

Name	Type	Description	Arm Group Labels	Other Names
bevasiranib	Drug	Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	B C

Outcomes Module

Measure	Description	Time Frame
Visual Acuity	avoidance of 3 or more lines of vision loss	week 60

Measure	Description	Time Frame
Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision		Week 60

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Denis O'Shaughnessy, Ph.D.	Senior VP of Clincial Development	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Consultants of Arizona (site 209)		Phoenix	Arizona	85014	United States
Associated Retina Consultants (site 286)

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lucentis®	Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
FG001	Bevasiranib 8 Weeks	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Lucentis	Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
BG001	Bevasiranib 8 Weeks	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
BG002	Bevasiranib 12 Weeks	Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

United States

Title	Measurements
	BG00061 BG00159 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Visual Acuity

avoidance of 3 or more lines of vision loss

Zero participants analyzed due to early termination of the study.

week 60

ID	Title	Description
OG000	Lucentis®	Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
OG001	Bevasiranib 8 Weeks	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
OG002	Bevasiranib 12 Weeks	Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision

Zero participants analyzed due to early termination of the study.

Week 60

ID	Title	Description
OG000	Lucentis	Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
OG001	Bevasiranib 8 Weeks	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks
OG002	Bevasiranib 12 Weeks	Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lucentis	Lucentis® (0.5mg) every 4 weeks. ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks.	26	112	71	112
EG001	Bevasiranib 8 Weeks	Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	28	112	85	112
EG002	Bevasiranib 12 Weeks	Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6. bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks	33	112	96	112

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Visual acuity decreased	Eye disorders	Non-systematic Assessment	EG0005 affected112 at risk EG0017 affected112 at risk EG00210 affected112 at risk
Endophthalmitis	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0014 affected112 at risk EG0021 affected112 at risk
Uveitis	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0022 affected112 at risk
Vitritis	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0013 affected112 at risk EG0020 affected112 at risk
Vitreous haemorrhage	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0022 affected112 at risk
Cataract	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Corneal oedema	Eye disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Hyphaema	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Iridocyclitis	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Macular degeneration	Eye disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Punctate keratitis	Eye disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Gastroduodenitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Pancreatitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Anaphylactic reaction	Immune system disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0022 affected112 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Keratitis herpetic	Infections and infestations	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Hip fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Upper limb fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Heart rate irregular	Investigations	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Intervertebral disc protusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected112 at risk EG0012 affected112 at risk EG0020 affected112 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0002 affected112 at risk EG0010 affected112 at risk EG0022 affected112 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0022 affected112 at risk
Transient ischemia attack	Nervous system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0022 affected112 at risk
Carotid artery stenosis	Nervous system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Dementia	Nervous system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Renal failure chronic	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0012 affected112 at risk EG0020 affected112 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0010 affected112 at risk EG0021 affected112 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0001 affected112 at risk EG0010 affected112 at risk EG0020 affected112 at risk
Thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 affected112 at risk EG0011 affected112 at risk EG0020 affected112 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Retinal haemorrhage	Eye disorders	Non-systematic Assessment	EG00011 affected112 at risk EG00116 affected112 at risk EG00222 affected112 at risk
Visual acuity reduced	Eye disorders	Non-systematic Assessment	EG0004 affected112 at risk EG0018 affected112 at risk EG00212 affected112 at risk
Conjunctival haemorrhage	Eye disorders	Non-systematic Assessment	EG00010 affected112 at risk EG0019 affected112 at risk EG00213 affected112 at risk
Vitreous detachment	Eye disorders	Non-systematic Assessment	EG0008 affected112 at risk EG00111 affected112 at risk EG00210 affected112 at risk
Vitreous floaters	Eye disorders	Non-systematic Assessment	EG0009 affected112 at risk EG00110 affected112 at risk EG0028 affected112 at risk
Eye pain	Eye disorders	Non-systematic Assessment	EG0006 affected112 at risk EG0017 affected112 at risk EG00212 affected112 at risk
Macular degeneration	Eye disorders	Non-systematic Assessment	EG0005 affected112 at risk EG0017 affected112 at risk EG0029 affected112 at risk
Cataract	Eye disorders	Non-systematic Assessment	EG0008 affected112 at risk EG0014 affected112 at risk EG0026 affected112 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0007 affected112 at risk EG0016 affected112 at risk EG0025 affected112 at risk
Intraocular pressure increased	Investigations	Non-systematic Assessment	EG0003 affected112 at risk EG0017 affected112 at risk EG00210 affected112 at risk

Study was terminated early.

Certain Agreements

ID	Term
D008268	Macular Degeneration

ID	Term
C554088	bevasiranib
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases