Macular Degeneration
Conditions
Keywords
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Brief summary
This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).
Interventions
1 drop per dosed eye per protocol.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* After completion of the preceding study (A5751010)
Exclusion criteria
* Serious heart, kidney and/or liver disease * Diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Adverse Events | Week 54 (initiation of A5751015 study) up to Week 198 | Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Weeks 54, every 18 weeks from Week 54 up to Week 198 | Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. |
| Number of Responders | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain. |
| Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. |
| Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline. |
| Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity. |
| Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. |
Countries
Japan
Participant flow
Pre-assignment details
All subjects received a 0.3 mg or 1 mg/eye EYE001 (pegaptanib sodium) intravitreal injection every 6 weeks for 48 weeks in the preceding study A5751010 (NCT00150202)
Participants by arm
| Arm | Count |
|---|---|
| EYE001 All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Not need to continue study | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | EYE001 |
|---|---|
| Age Continuous | 73.3 years STANDARD_DEVIATION 8.1 |
| Age, Customized 18-64 years | 7 participants |
| Age, Customized < 18 years | 0 participants |
| Age, Customized >=65 years | 54 participants |
| Region of Enrollment Japan | 61 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 61 |
| serious Total, serious adverse events | 16 / 61 |
Outcome results
Primary
Summary of Adverse Events
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
Time frame: Week 54 (initiation of A5751015 study) up to Week 198
Population: Intent-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EYE001 | Summary of Adverse Events | Subjects with adverse events | 57 participants |
| EYE001 | Summary of Adverse Events | Subjects with serious adverse events | 16 participants |
| EYE001 | Summary of Adverse Events | Subjects with ophthalmic adverse event | 47 participants |
| EYE001 | Summary of Adverse Events | Subjects with severe adverse events | 4 participants |
| EYE001 | Summary of Adverse Events | Severe Myocardial Infarction | 1 participants |
| EYE001 | Summary of Adverse Events | Severe Femur Fracture | 1 participants |
| EYE001 | Summary of Adverse Events | Severe Gastric Cancer | 1 participants |
| EYE001 | Summary of Adverse Events | Severe Pancreatic Carcinoma | 1 participants |
| EYE001 | Summary of Adverse Events | Subjects discontinued due to adverse events | 4 participants |
| EYE001 | Summary of Adverse Events | Subjects with dose reduction or temporary disconti | 4 participants |
Secondary
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 54 | -3.2 letters | Standard Deviation 13.36 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 72 | -3.3 letters | Standard Deviation 15.25 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 90 | -4.7 letters | Standard Deviation 15.97 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 108 | -8.6 letters | Standard Deviation 16.83 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 126 | -8.6 letters | Standard Deviation 18.36 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 144 | -10.1 letters | Standard Deviation 17.95 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 162 | -10.4 letters | Standard Deviation 16.7 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 180 | -10.4 letters | Standard Deviation 16.63 |
| EYE001 | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Week 198 | -10.3 letters | Standard Deviation 16.42 |
Secondary
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Time frame: Weeks 54, every 18 weeks from Week 54 up to Week 198
Population: Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72.~Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 72 | -0.1 letters | Standard Deviation 6.72 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 90 | -1.4 letters | Standard Deviation 9.63 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 108 | -4.8 letters | Standard Deviation 11.69 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 126 | -4.5 letters | Standard Deviation 13.25 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 144 | -6.1 letters | Standard Deviation 13.45 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 162 | -6.3 letters | Standard Deviation 12.99 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 180 | -6.3 letters | Standard Deviation 12.77 |
| EYE001 | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Week 198 | -6.2 letters | Standard Deviation 12.92 |
Secondary
Number of Responders
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EYE001 | Number of Responders | Week 54 | 41 participants |
| EYE001 | Number of Responders | Week 72 | 41 participants |
| EYE001 | Number of Responders | Week 90 | 37 participants |
| EYE001 | Number of Responders | Week 108 | 33 participants |
| EYE001 | Number of Responders | Week 126 | 32 participants |
| EYE001 | Number of Responders | Week 144 | 30 participants |
| EYE001 | Number of Responders | Week 162 | 29 participants |
| EYE001 | Number of Responders | Week 180 | 29 participants |
| EYE001 | Number of Responders | Week 198 | 30 participants |
Secondary
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 54 | 4 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 72 | 7 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 90 | 7 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 108 | 6 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 126 | 6 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 144 | 5 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 162 | 6 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 180 | 5 participants |
| EYE001 | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Week 198 | 5 participants |
Secondary
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 54 | 24 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 72 | 20 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 90 | 21 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 108 | 16 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 126 | 17 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 144 | 15 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 162 | 15 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 180 | 15 participants |
| EYE001 | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Week 198 | 15 participants |
Secondary
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.
Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 144 | 7 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 54 | 0 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 72 | 1 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 90 | 4 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 108 | 7 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 126 | 6 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 162 | 6 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 180 | 7 participants |
| EYE001 | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Week 198 | 7 participants |