Trial Outcomes & Findings for Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD) (NCT NCT01148511)
NCT ID: NCT01148511
Last Updated: 2013-05-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2013-05-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Exposed to Study Drug
STARTED
|
99
|
0
|
0
|
|
Exposed to Study Drug
COMPLETED
|
93
|
0
|
0
|
|
Exposed to Study Drug
NOT COMPLETED
|
6
|
0
|
0
|
|
Randomized
STARTED
|
0
|
48
|
45
|
|
Randomized
COMPLETED
|
0
|
38
|
39
|
|
Randomized
NOT COMPLETED
|
0
|
10
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Exposed to Study Drug
Protocol Violation
|
2
|
0
|
0
|
|
Exposed to Study Drug
Lost to Follow-up
|
4
|
0
|
0
|
|
Randomized
Adverse Event
|
0
|
1
|
0
|
|
Randomized
Protocol Violation
|
0
|
2
|
1
|
|
Randomized
Lost to Follow-up
|
0
|
1
|
1
|
|
Randomized
Consent withdrawal
|
0
|
5
|
3
|
|
Randomized
Other
|
0
|
1
|
1
|
Baseline Characteristics
Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Treat and Extend
n=48 Participants
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.
|
Treat and Observe
n=45 Participants
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.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
70.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: 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.
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.
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12
|
-0.18 logMAR
Interval -0.88 to 0.76
|
-0.12 logMAR
Interval -0.88 to 1.56
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: 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.
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.
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Change in Letter Count From Baseline to Month 12
|
-9 Letters
Interval -44.0 to 38.0
|
-6 Letters
Interval -44.0 to 78.0
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: 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.
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.
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Letter Count From Baseline to Month 12
< 35 letters
|
7.9 Percentage of patients
|
7.7 Percentage of patients
|
|
Letter Count From Baseline to Month 12
≥ 35 letters
|
92.1 Percentage of patients
|
92.3 Percentage of patients
|
|
Letter Count From Baseline to Month 12
gain ≥ 15 letter
|
34.2 Percentage of patients
|
23.1 Percentage of patients
|
|
Letter Count From Baseline to Month 12
gain < 15 letters or loss
|
65.8 Percentage of patients
|
76.9 Percentage of patients
|
|
Letter Count From Baseline to Month 12
loss > 15 letters
|
10.5 Percentage of patients
|
10.3 Percentage of patients
|
|
Letter Count From Baseline to Month 12
loss ≤ 15 letters or gained letter
|
89.5 Percentage of patients
|
89.7 Percentage of patients
|
|
Letter Count From Baseline to Month 12
loss ≥ 30 letters
|
2.6 Percentage of patients
|
5.1 Percentage of patients
|
|
Letter Count From Baseline to Month 12
loss < 30 letters or gained letter
|
97.4 Percentage of patients
|
94.9 Percentage of patients
|
|
Letter Count From Baseline to Month 12
gain ≥ 0 letter
|
76.3 Percentage of patients
|
61.5 Percentage of patients
|
|
Letter Count From Baseline to Month 12
Loss
|
23.7 Percentage of patients
|
38.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: 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.
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Number of Visits
|
12.0 Visits
Interval 10.0 to 15.0
|
15.0 Visits
Interval 12.0 to 15.0
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: 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.
Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Follow-up Duration
|
364.5 Days
Interval 310.0 to 396.0
|
366.0 Days
Interval 320.0 to 386.0
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: 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.
Retinal thickness was measured using Optical Coherence Tomography (OCT).
Outcome measures
| Measure |
Treat and Extend
n=38 Participants
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.
|
Treat and Observe
n=39 Participants
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.
|
|---|---|---|
|
Change in Central Retinal Thickness From Baseline to Month 12
|
88.5 µm
Interval -190.0 to 584.0
|
61.0 µm
Interval -470.0 to 500.0
|
SECONDARY outcome
Timeframe: Visits 2, 6, 9, 12, and 15 (up to 12 months)Population: 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.
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.
Outcome measures
| Measure |
Treat and Extend
n=27 Participants
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.
|
Treat and Observe
n=30 Participants
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.
|
|---|---|---|
|
Quality of Life
Visit 6
|
71.0 Units on a scale
Interval 65.0 to 83.0
|
69.5 Units on a scale
Interval 60.0 to 79.0
|
|
Quality of Life
Visit 9
|
69.0 Units on a scale
Interval 63.0 to 80.0
|
72.5 Units on a scale
Interval 62.0 to 92.0
|
|
Quality of Life
Visit 2
|
70.0 Units on a scale
Interval 57.0 to 87.0
|
73.0 Units on a scale
Interval 62.0 to 89.0
|
|
Quality of Life
Visit 12
|
72.0 Units on a scale
Interval 64.0 to 84.0
|
71.0 Units on a scale
Interval 60.0 to 91.0
|
|
Quality of Life
Visit 15
|
69.0 Units on a scale
Interval 64.0 to 80.0
|
70.5 Units on a scale
Interval 57.0 to 85.0
|
Adverse Events
Treat and Extend
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Treat and Observe
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Before Randomization
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treat and Extend
n=48 participants at risk
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.
|
Treat and Observe
n=45 participants at risk
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.
|
Before Randomization
n=6 participants at risk
These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
16.7%
1/6
Safety population: All patients who received study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/48
Safety population: All patients who received study drug.
|
2.2%
1/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Lower and upper limb fracture
|
2.1%
1/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Psychiatric disorders
Aphasia Syncope
|
0.00%
0/48
Safety population: All patients who received study drug.
|
2.2%
1/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Renal and urinary disorders
Azotemia
|
0.00%
0/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
16.7%
1/6
Safety population: All patients who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.1%
1/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
2.1%
1/48
Safety population: All patients who received study drug.
|
0.00%
0/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Surgical and medical procedures
Vascular graft
|
2.1%
1/48
Safety population: All patients who received study drug.
|
2.2%
1/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
Other adverse events
| Measure |
Treat and Extend
n=48 participants at risk
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.
|
Treat and Observe
n=45 participants at risk
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.
|
Before Randomization
n=6 participants at risk
These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
|
|---|---|---|---|
|
Eye disorders
Adenoviral conjunctivitis
|
4.2%
2/48
Safety population: All patients who received study drug.
|
6.7%
3/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
16.7%
8/48
Safety population: All patients who received study drug.
|
11.1%
5/45
Safety population: All patients who received study drug.
|
0.00%
0/6
Safety population: All patients who received study drug.
|
|
Vascular disorders
Hypertension
|
2.1%
1/48
Safety population: All patients who received study drug.
|
4.4%
2/45
Safety population: All patients who received study drug.
|
16.7%
1/6
Safety population: All patients who received study drug.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER