| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Cochran-Mantel-Haenszel | Stratification factors (HbA1c and baseline visual acuity categories) | 0.0003 | Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05. | Odds Ratio (OR) | 4.85 | | | 2-Sided | 95 | 1.92 | 12.28 | | | | No | Superiority or Other |
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| 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 | 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). | Posted | | Mean | Standard Deviation | Letters | | Baseline, Weeks 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase | Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy. | 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). | Posted | | Number | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 54 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Letters | | Baseline, Weeks 30, 36, 42, 48 and 54 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| Secondary | Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase | Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy. | 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). | Posted | | Number | | Participants | | Weeks 24 to 54 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Letters | | Baseline, Weeks 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline, Weeks 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline, Weeks 6, 12, 18, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | Sham in Double Masked, Then Pegaptanib Sodium in Open Phase |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Letters | | Baseline, Weeks 30, 36, 42, 48, and 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
|
| 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. | 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). | Posted | | Number | | Participants | | Baseline, Weeks 30, 36, 42, 48, and 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline, Weeks 30, 36, 42, 48, and 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Number | | Participants | | Baseline and Week 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 54 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | Sham in Double Masked, Then Pegaptanib Sodium in Open Phase | |
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