Comparison of Safety, Effectiveness and Quality of Life O... | NCT01148511

NCT01148511

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treat and Extend	Experimental	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.	Drug: Ranibizumab 0.5 mg
Treat and Observe	Active Comparator	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.	Drug: Ranibizumab 0.5 mg

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab 0.5 mg	Drug	Ranibizumab was supplied as a sterile solution in sealed glass vials.	Treat and Extend Treat and Observe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12	Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.	Baseline to Month 12
Change in Letter Count From Baseline to Month 12	Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.	Baseline to Month 12

Secondary Outcomes

Measure	Description	Time Frame
Letter Count From Baseline to Month 12	Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.	Baseline to Month 12
Number of Visits

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Adana			Turkey (Türkiye)
Novartis Investigational Site

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	All Patients	All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
FG001	Treat and Extend

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

Masking Info

Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.

FG0010 subjectsPatients were not randomized to this group until the Randomized Period.

FG0020 subjectsPatients were not randomized to this group until the Randomized Period.

Safety population: All patients who received study drug (n=99). Not all patients who received study drug were randomized into the 2 treatment groups (n=93) due to discontinuation from the study in the first Period of the study. Baseline Characteristics are only reported for the randomized (n=93) patients.

Arm/Group Information

ID	Title	Description
BG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
BG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00048 BG00145 BG00293

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
	OG000-0.18(-0.88 to 0.76) OG001-0.12(-0.88 to 1.56)

Primary

Change in Letter Count From Baseline to Month 12

Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Median

Full Range

Letters

Baseline to Month 12

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Secondary

Letter Count From Baseline to Month 12

Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Number

Percentage of patients

Baseline to Month 12

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Secondary

Number of Visits

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Median

Full Range

Visits

Baseline to Month 12

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Units	Counts
Participants

Secondary

Follow-up Duration

Follow-up duration was defined as the number of days from Baseline to study discontinuation.

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Mean

Full Range

Days

Baseline to Month 12

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Units

Secondary

Change in Central Retinal Thickness From Baseline to Month 12

Retinal thickness was measured using Optical Coherence Tomography (OCT).

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Median

Full Range

µm

Baseline to Month 12

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Secondary

Quality of Life

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.

Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.

Posted

Median

Full Range

Units on a scale

Visits 2, 6, 9, 12, and 15 (up to 12 months)

ID	Title	Description
OG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
OG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treat and Extend	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.	5	48	10	48
EG001	Treat and Observe	Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.	3	45	8	45
EG002	Before Randomization	These 6 patients were exposed to study drug but discontinued from the study prior to randomization.	2	6	1	6

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected48 at risk EG0010 affected45 at risk EG0021 affected6 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected48 at risk EG0011 affected45 at risk EG0020 affected6 at risk
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0010 affected45 at risk EG0020 affected6 at risk
Lower and upper limb fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0010 affected45 at risk EG0020 affected6 at risk
Aphasia Syncope	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected48 at risk EG0011 affected45 at risk EG0020 affected6 at risk
Azotemia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected48 at risk EG0010 affected45 at risk EG0021 affected6 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0010 affected45 at risk EG0020 affected6 at risk
Herpes zoster	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0010 affected45 at risk EG0020 affected6 at risk
Vascular graft	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0011 affected45 at risk EG0020 affected6 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adenoviral conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected48 at risk EG0013 affected45 at risk EG0020 affected6 at risk
Influenza	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected48 at risk EG0015 affected45 at risk EG0020 affected6 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected48 at risk EG0012 affected45 at risk EG0021 affected6 at risk

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases
D014603	Uveal Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
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

Units	Counts
Participants	OG00038 OG00139