Efficacy and Safety of Ranibizumab (Intravitreal Injectio... | NCT00901186

ID	Type	Description	Link
2009-010825-37	EudraCT Number

Status Module

Description 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
RFB002	Experimental	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.	Drug: RFB002
Laser photocoagulation	Active Comparator	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.	Procedure: Laser photocoagulation

Name	Type	Description	Arm Group Labels	Other Names
RFB002	Drug	0.5 mg	RFB002	Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)	Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.	Baseline, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Improvement in BCVA	Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.	12 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis Pharmaceuticals	Novartis	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Almería	Andalusia	04009	Spain
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
FG001	Laser Photocoagulation

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
BG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00039 BG00143 BG00282

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG0009.41± 9.15 OG0015.79± 9.40

Secondary

Percentage of Participants With Improvement in BCVA

Posted

Number

Percentage of participants

12 months

ID	Title	Description
OG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
OG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Units	Counts

Secondary

Evolution of Mean Change From Baseline in BCVA by Study Visit

ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month BCVA values were included in the analysis.

Posted

Mean

Standard Deviation

letters

Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

ID	Title	Description
OG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
OG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Secondary

Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.

VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.

Posted

Number

Percentage of participants

12 months

ID	Title	Description
OG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
OG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit

CRT was assessed by Optical Coherence Tomography (OCT).

Posted

Mean

Standard Deviation

micrometers

Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

ID	Title	Description
OG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
OG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Units	Counts
Participants

Secondary

Percentage of CRT Change From Baseline by Study Visit

CRT was assessed by Optical Coherence Tomography (OCT).

Posted

Mean

Standard Deviation

Percentage change

Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

ID	Title	Description
OG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
OG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RFB002	RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.			3	39	2	39
EG001	Laser Photocoagulation	At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.			2	43	3	43

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected43 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected43 at risk
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected39 at risk EG0011 affected43 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected43 at risk
Necrosis ischaemic	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected39 at risk EG0010 affected43 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment		EG0002 affected39 at risk EG0010 affected43 at risk
Cataract operation	Surgical and medical procedures	MedDRA	Systematic Assessment		EG0000 affected39 at risk EG0013 affected43 at risk

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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