Diabetic Mellitus, Macular Edema, Retinal Disease
Conditions
Keywords
diabetic macular edema, Macugen, sham-controlled study
Brief summary
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
Detailed description
During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
Interventions
Intravitreal injection of 0.3 mg every 6 weeks
OTHERsham injection
sham injection every 6 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type I, or Type II diabetic subjects * Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive
Exclusion criteria
* Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months * HbA1C level \>12% or recent signs of uncontrolled diabetes * Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | Baseline and Week 24 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Acuity (VA): Double Masked Phase | Baseline, Weeks 6, 12, 18, and 24 | Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts |
| Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Up to 24 weeks | Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy. |
| Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | Baseline and Week 54 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Change From Baseline in Visual Acuity (VA): Open Phase | Baseline, Weeks 30, 36, 42, 48 and 54 | Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Weeks 24 to 54 | Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Acuity Over Time at Each Time Point: Open Phase | Baseline, Weeks 30, 36, 42, 48, and 54 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Baseline, Weeks 30, 36, 42, 48, and 54 | Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts. Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more. |
| Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Baseline, Weeks 30, 36, 42, 48, and 54 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Baseline, Weeks 6, 12, 18, and 24 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase | Baseline and Week 54 | Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. |
| Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Baseline and Week 54 | NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores. Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question. Positive change indicated improvement. |
| Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | Baseline and Week 54 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Baseline, Weeks 6, 12, 18, and 24 | Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts. Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more. |
| Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Baseline, Weeks 6, 12, 18, and 24 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | Baseline and Week 24 | Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts. |
| Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase | Baseline and Week 24 | OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured. |
| Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Baseline and Week 24 | NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores. Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question. Positive change indicated improvement. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegaptanib Sodium Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54). | 123 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase. | 120 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Masked Phase (Up to Week 24) | Adverse Event | 5 | 2 |
| Double Masked Phase (Up to Week 24) | Lack of Efficacy | 1 | 1 |
| Double Masked Phase (Up to Week 24) | Withdrawal by Subject | 0 | 1 |
| Open Phase (Week 24 up to Week 54) | Adverse Event | 3 | 8 |
| Open Phase (Week 24 up to Week 54) | Lack of Efficacy | 1 | 2 |
| Open Phase (Week 24 up to Week 54) | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Pegaptanib Sodium | Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 71 Participants | 71 Participants | 142 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 49 Participants | 101 Participants |
| Sex: Female, Male Female | 58 Participants | 55 Participants | 113 Participants |
| Sex: Female, Male Male | 65 Participants | 65 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 72 / 123 | 53 / 120 | 83 / 123 | 40 / 112 |
| serious Total, serious adverse events | 10 / 123 | 10 / 120 | 19 / 123 | 7 / 112 |
Outcome results
Primary
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline and Week 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | 25 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | 6 Participants |
Comparison: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.p-value: 0.000395% CI: [1.92, 12.28]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Visual Acuity (VA): Double Masked Phase
Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts
Time frame: Baseline, Weeks 6, 12, 18, and 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 6 | 2.7 Letters | Standard Deviation 5.39 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 12 | 3.2 Letters | Standard Deviation 6.19 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 18 | 2.8 Letters | Standard Deviation 7.84 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 24 | 3.1 Letters | Standard Deviation 7.5 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 24 | -1.2 Letters | Standard Deviation 8.8 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 6 | 0.2 Letters | Standard Deviation 5.9 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 18 | 0.1 Letters | Standard Deviation 8.14 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Double Masked Phase | Week 12 | -0.6 Letters | Standard Deviation 8.6 |
Comparison: Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.p-value: 0.000695% CI: [1.1, 3.94]ANCOVA
Comparison: Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.p-value: 0.000195% CI: [1.81, 5.58]ANCOVA
Comparison: Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.p-value: 0.009695% CI: [0.65, 4.65]ANCOVA
Comparison: Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.p-value: <0.000195% CI: [2.19, 6.32]ANCOVA
Secondary
Change From Baseline in Visual Acuity (VA): Open Phase
Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Weeks 30, 36, 42, 48 and 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Open Phase | Week 36 | 4.4 Letters | Standard Deviation 8.43 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Open Phase | Week 48 | 4.1 Letters | Standard Deviation 8.52 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Open Phase | Week 42 | 4.3 Letters | Standard Deviation 8.27 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Open Phase | Week 54 | 3.6 Letters | Standard Deviation 8.93 |
| Pegaptanib Sodium | Change From Baseline in Visual Acuity (VA): Open Phase | Week 30 | 3.5 Letters | Standard Deviation 8.62 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Open Phase | Week 54 | -0.5 Letters | Standard Deviation 10.48 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Open Phase | Week 30 | -0.1 Letters | Standard Deviation 7.78 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Open Phase | Week 36 | 0.6 Letters | Standard Deviation 7.91 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Open Phase | Week 42 | 0.3 Letters | Standard Deviation 8.86 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in Visual Acuity (VA): Open Phase | Week 48 | -0.8 Letters | Standard Deviation 10.09 |
Secondary
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Time frame: Up to 24 weeks
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Focal/Grid Lase | 3 Participants |
| Pegaptanib Sodium | Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Vitrectomy | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Vitrectomy | 1 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Focal/Grid Lase | 1 Participants |
Secondary
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline and Week 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | 28 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | 15 Participants |
Secondary
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Time frame: Weeks 24 to 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Focal/Grid Laser | 3 Participants |
| Pegaptanib Sodium | Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Vitrectomy | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Focal/Grid Laser | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Vitrectomy | 0 Participants |
Other Pre-specified
Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase
NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores. Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question. Positive change indicated improvement.
Time frame: Baseline and Week 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Ocular Pain (n=123, 118) | -0.5 Units on a scale | Standard Deviation 18.35 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Role Difficulties (n=123, 118) | -1.6 Units on a scale | Standard Deviation 23.36 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Distance Vision Activities (n=123, 118) | 0.5 Units on a scale | Standard Deviation 15.92 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Dependency (n=123, 118) | -0.1 Units on a scale | Standard Deviation 18.11 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | General Vision (n=123, 118) | 2.8 Units on a scale | Standard Deviation 17.8 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Driving (n=80, 73) | -1.4 Units on a scale | Standard Deviation 14.34 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Social Functioning (n=123, 117) | 0.7 Units on a scale | Standard Deviation 17.77 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Color Vision (n=119, 115) | 2.9 Units on a scale | Standard Deviation 15.67 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Near Vision Activities (n=123, 118) | -0.5 Units on a scale | Standard Deviation 19.01 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Peripheral Vision (n=123, 117) | 1.4 Units on a scale | Standard Deviation 23.15 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Mental Health (n=123, 118) | 0.5 Units on a scale | Standard Deviation 19.05 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Composite Score (n=123, 118) | 0.5 Units on a scale | Standard Deviation 10.37 |
| Pegaptanib Sodium | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | General Health (n=123, 118) | -0.2 Units on a scale | Standard Deviation 18.8 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Composite Score (n=123, 118) | -1.1 Units on a scale | Standard Deviation 10.85 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | General Health (n=123, 118) | -2.1 Units on a scale | Standard Deviation 20.56 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | General Vision (n=123, 118) | 0.7 Units on a scale | Standard Deviation 19.2 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Ocular Pain (n=123, 118) | 0.6 Units on a scale | Standard Deviation 18.77 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Near Vision Activities (n=123, 118) | 0.6 Units on a scale | Standard Deviation 18.6 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Distance Vision Activities (n=123, 118) | -1.3 Units on a scale | Standard Deviation 15.8 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Social Functioning (n=123, 117) | -1.7 Units on a scale | Standard Deviation 17.13 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Mental Health (n=123, 118) | -0.5 Units on a scale | Standard Deviation 17.91 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Role Difficulties (n=123, 118) | -1.1 Units on a scale | Standard Deviation 21.72 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Dependency (n=123, 118) | -1.1 Units on a scale | Standard Deviation 18.38 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Driving (n=80, 73) | -5.7 Units on a scale | Standard Deviation 20.84 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Color Vision (n=119, 115) | -0.9 Units on a scale | Standard Deviation 19.85 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase | Peripheral Vision (n=123, 117) | -4.1 Units on a scale | Standard Deviation 21.26 |
Other Pre-specified
Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase
NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores. Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question. Positive change indicated improvement.
Time frame: Baseline and Week 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | General Vision (n=116, 110) | 4.7 Units on a scale | Standard Deviation 15.68 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Role Difficulties (n=116, 110) | 0.5 Units on a scale | Standard Deviation 23.34 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Distance Vision Activities (n=116, 110) | 1.4 Units on a scale | Standard Deviation 15.97 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Dependency (n=116, 110) | 0.9 Units on a scale | Standard Deviation 19.3 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | General Health (n=116, 110) | -1.5 Units on a scale | Standard Deviation 20.13 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Driving (n=74, 69) | -2.0 Units on a scale | Standard Deviation 18.28 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Social Functioning (n=116, 110) | -2.5 Units on a scale | Standard Deviation 17.92 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Color Vision (n=112, 109) | -0.4 Units on a scale | Standard Deviation 15 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Ocular Pain (n=116, 110) | 1.8 Units on a scale | Standard Deviation 17.15 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Peripheral Vision (n=115, 110) | 0.9 Units on a scale | Standard Deviation 22.2 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Mental Health (n=116, 110) | 2.1 Units on a scale | Standard Deviation 19.85 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Composite Score (n=116, 110) | 0.8 Units on a scale | Standard Deviation 11.15 |
| Pegaptanib Sodium | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Near Vision Activities (n=116, 110) | 1.5 Units on a scale | Standard Deviation 17.28 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Composite Score (n=116, 110) | -1.8 Units on a scale | Standard Deviation 11.16 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Near Vision Activities (n=116, 110) | -0.6 Units on a scale | Standard Deviation 19.92 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | General Health (n=116, 110) | -1.8 Units on a scale | Standard Deviation 20.52 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | General Vision (n=116, 110) | 0.7 Units on a scale | Standard Deviation 17.96 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Ocular Pain (n=116, 110) | 0.0 Units on a scale | Standard Deviation 17.35 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Distance Vision Activities (n=116, 110) | -0.5 Units on a scale | Standard Deviation 15.46 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Social Functioning (n=116, 110) | -2.5 Units on a scale | Standard Deviation 17.25 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Mental Health (n=116, 110) | -2.7 Units on a scale | Standard Deviation 20.43 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Role Difficulties (n=116, 110) | -0.6 Units on a scale | Standard Deviation 20.9 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Dependency (n=116, 110) | -3.3 Units on a scale | Standard Deviation 18.76 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Driving (n=74, 69) | -7.2 Units on a scale | Standard Deviation 26.03 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Color Vision (n=112, 109) | -2.8 Units on a scale | Standard Deviation 18.43 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase | Peripheral Vision (n=115, 110) | -3.4 Units on a scale | Standard Deviation 22.07 |
Other Pre-specified
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase
Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts. Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more.
Time frame: Baseline, Weeks 6, 12, 18, and 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 1 - 9 Letters | 28 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: No Change/Gained 1 - 9 Letters | 74 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Gained 10 - 14 Letters | 12 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Gained 15 Letters or More | 3 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 15 Letters or More | 1 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 10 - 14 Letters | 1 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 1 - 9 Letters | 33 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: No Change/Gained 1 - 9 Letters | 76 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Gained 10 - 14 Letters | 12 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Gained 15 Letters or More | 5 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 15 Letters or More | 2 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 10 - 14 Letters | 3 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 1 - 9 Letters | 33 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: No Change/Gained 1 - 9 Letters | 61 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Gained 10 - 14 Letters | 15 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Gained 15 Letters or More | 9 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 15 Letters or More | 1 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 10 - 14 Letters | 6 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: No Change/Gained 1 - 9 Letters | 61 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Gained 10 - 14 Letters | 18 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Gained 15 Letters or More | 7 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 1 - 9 Letters | 30 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 15 Letters or More | 1 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 10 - 14 Letters | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 10 - 14 Letters | 5 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 1 - 9 Letters | 40 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 1 - 9 Letters | 43 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: No Change/Gained 1 - 9 Letters | 71 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: No Change/Gained 1 - 9 Letters | 59 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Gained 10 - 14 Letters | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: No Change/Gained 1 - 9 Letters | 62 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Gained 15 Letters or More | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 15 Letters or More | 4 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 15 Letters or More | 5 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Gained 10 - 14 Letters | 6 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 10 - 14 Letters | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Gained 10 - 14 Letters | 5 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Lost 1 - 9 Letters | 50 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Gained 15 Letters or More | 2 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: No Change/Gained 1 - 9 Letters | 54 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 6: Lost 10 - 14 Letters | 2 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Gained 10 - 14 Letters | 7 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 15 Letters or More | 9 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 12: Gained 15 Letters or More | 1 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Gained 15 Letters or More | 1 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 15 Letters or More | 4 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 24: Lost 1 - 9 Letters | 41 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase | Week 18: Lost 10 - 14 Letters | 3 Participants |
Other Pre-specified
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase
Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts. Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 - 14 letters; Lost 1 - 9 Letters; No change or gained 1 - 9 letters; Gained 10 - 14 letters; Gained 15 letters or more.
Time frame: Baseline, Weeks 30, 36, 42, 48, and 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: No Change or Gained 1 - 9 Letters | 59 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 1 - 9 Letters | 22 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Gained 10 - 14 Letters | 16 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 10 - 14 Letters | 2 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Gained 15 Letters or More | 13 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: No Change or Gained 1 - 9 Letters | 64 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 15 Letters or More | 2 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Gained 15 Letters or More | 11 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 10 - 14 Letters | 5 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Gained 10 - 14 Letters | 13 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 1 - 9 Letters | 27 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: No Change or Gained 1 - 9 Letters | 53 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: No Change or Gained 1 - 9 letters | 51 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Gained 15 Letters or More | 13 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Gained 10 - 14 Letters | 15 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 15 Letters or More | 3 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Gained 15 Letters or More | 16 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 15 Letters or More | 2 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 15 Letters or More | 3 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 1 - 9 Letters | 31 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 10 - 14 Letters | 3 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 10 - 14 Letters | 2 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 1 - 9 Letters | 27 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 10 - 14 Letters | 1 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: No Change or Gained 1 - 9 Letters | 55 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 1 - 9 Letters | 24 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Gained 10 - 14 Letters | 15 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Gained 10 - 14 Letters | 15 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Gained 15 Letters or More | 13 Participants |
| Pegaptanib Sodium | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 15 Letters or More | 4 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Gained 15 Letters or More | 2 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 15 Letters or More | 8 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 10 - 14 Letters | 5 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Lost 1 - 9 Letters | 31 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: No Change or Gained 1 - 9 Letters | 61 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Gained 10 - 14 Letters | 7 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 30: Gained 15 Letters or More | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 15 Letters or More | 6 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 10 - 14 Letters | 8 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Lost 1 - 9 Letters | 25 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: No Change or Gained 1 - 9 Letters | 63 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Gained 10 - 14 Letters | 10 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 36: Gained 15 Letters or More | 0 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 15 Letters or More | 8 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 10 - 14 Letters | 10 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Lost 1 - 9 Letters | 26 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: No Change or Gained 1 - 9 Letters | 53 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Gained 10 - 14 Letters | 12 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 42: Gained 15 Letters or More | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 15 Letters or More | 13 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 10 - 14 Letters | 9 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Lost 1 - 9 Letters | 24 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: No Change or Gained 1 - 9 letters | 54 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Gained 10 - 14 Letters | 9 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 48: Gained 15 Letters or More | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 15 Letters or More | 10 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 10 - 14 Letters | 10 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Lost 1 - 9 Letters | 28 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: No Change or Gained 1 - 9 Letters | 49 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase | Week 54: Gained 10 - 14 Letters | 13 Participants |
Other Pre-specified
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Weeks 6, 12, 18, and 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 6 | 59.5 Letters | Standard Deviation 8.24 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 18 | 59.7 Letters | Standard Deviation 9.66 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 12 | 60.0 Letters | Standard Deviation 9.32 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 24 | 59.9 Letters | Standard Deviation 9.89 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Baseline | 56.8 Letters | Standard Deviation 8.39 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 24 | 55.7 Letters | Standard Deviation 12.18 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Baseline | 56.9 Letters | Standard Deviation 8.15 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 6 | 57.1 Letters | Standard Deviation 10.29 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 12 | 56.4 Letters | Standard Deviation 11.65 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase | Week 18 | 57.1 Letters | Standard Deviation 11.52 |
Other Pre-specified
Mean Visual Acuity Over Time at Each Time Point: Open Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Weeks 30, 36, 42, 48, and 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 36 | 61.6 Letters | Standard Deviation 10.47 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Baseline | 57.2 Letters | Standard Deviation 8.07 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 30 | 60.7 Letters | Standard Deviation 10.52 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 42 | 61.5 Letters | Standard Deviation 10.01 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 48 | 61.3 Letters | Standard Deviation 10.11 |
| Pegaptanib Sodium | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 54 | 60.8 Letters | Standard Deviation 10.63 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 48 | 55.9 Letters | Standard Deviation 13.61 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 42 | 57.0 Letters | Standard Deviation 12.24 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Baseline | 56.7 Letters | Standard Deviation 8.28 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 54 | 56.2 Letters | Standard Deviation 13.71 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 30 | 56.6 Letters | Standard Deviation 11.25 |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Mean Visual Acuity Over Time at Each Time Point: Open Phase | Week 36 | 57.3 Letters | Standard Deviation 11.59 |
Other Pre-specified
Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.
Time frame: Baseline and Week 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase | ≥25% Decrease From Baseline | 42 Participants |
| Pegaptanib Sodium | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase | ≥50% Decrease From Baseline | 11 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase | ≥25% Decrease From Baseline | 25 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase | ≥50% Decrease From Baseline | 8 Participants |
Other Pre-specified
Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase
Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.
Time frame: Baseline and Week 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase | ≥25% Decrease From Baseline | 56 Participants |
| Pegaptanib Sodium | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase | ≥50% Decrease From Baseline | 21 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase | ≥25% Decrease From Baseline | 38 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase | ≥50% Decrease From Baseline | 16 Participants |
Other Pre-specified
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Weeks 6, 12, 18, and 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 6 | 15 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 12 | 17 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 18 | 24 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 24 | 25 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 24 | 6 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 6 | 3 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 18 | 8 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase | Week 12 | 8 Participants |
Other Pre-specified
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, Weeks 30, 36, 42, 48, and 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 36 | 26 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 48 | 31 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 42 | 29 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 54 | 28 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 30 | 26 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 54 | 15 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 30 | 7 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 36 | 10 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 42 | 15 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase | Week 48 | 12 Participants |
Other Pre-specified
Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline and Week 24
Population: Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥15 Letter Improvement | 7 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥5 Letter Improvement | 49 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥0 Letter Improvement | 86 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥15 Letter Improvement | 1 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥5 Letter Improvement | 31 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase | ≥0 Letter Improvement | 65 Participants |
Other Pre-specified
Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline and Week 54
Population: Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥15 Letter Improvement | 13 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥5 Letter Improvement | 45 Participants |
| Pegaptanib Sodium | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥0 Letter Improvement | 83 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥15 Letter Improvement | 2 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥5 Letter Improvement | 40 Participants |
| Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase | ≥0 Letter Improvement | 64 Participants |