Trial Outcomes & Findings for A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema (NCT NCT01100307)

Last Updated: 2013-08-23

Results Overview

Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

243 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2013-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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.
Double Masked Phase (Up to Week 24) STARTED	123	120
Double Masked Phase (Up to Week 24) COMPLETED	117	116
Double Masked Phase (Up to Week 24) NOT COMPLETED	6	4
Open Phase (Week 24 up to Week 54) STARTED	116	112
Open Phase (Week 24 up to Week 54) COMPLETED	110	99
Open Phase (Week 24 up to Week 54) NOT COMPLETED	6	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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.
Double Masked Phase (Up to Week 24) Lack of Efficacy	1	1
Double Masked Phase (Up to Week 24) Withdrawal by Subject	0	1
Double Masked Phase (Up to Week 24) Adverse Event	5	2
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
Open Phase (Week 24 up to Week 54) Adverse Event	3	8

Baseline Characteristics

A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.	Total n=243 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	55 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	65 Participants n=7 Participants	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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	6 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
Change From Baseline in Visual Acuity (VA): Double Masked Phase Week 18	2.8 Letters Standard Deviation 7.84	0.1 Letters Standard Deviation 8.14
Change From Baseline in Visual Acuity (VA): Double Masked Phase Week 6	2.7 Letters Standard Deviation 5.39	0.2 Letters Standard Deviation 5.90
Change From Baseline in Visual Acuity (VA): Double Masked Phase Week 12	3.2 Letters Standard Deviation 6.19	-0.6 Letters Standard Deviation 8.60
Change From Baseline in Visual Acuity (VA): Double Masked Phase Week 24	3.1 Letters Standard Deviation 7.50	-1.2 Letters Standard Deviation 8.80

SECONDARY outcome

Timeframe: Up to 24 weeks

Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase Focal/Grid Lase	3 Participants	1 Participants
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase Vitrectomy	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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).

Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
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	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
Change From Baseline in Visual Acuity (VA): Open Phase Week 30	3.5 Letters Standard Deviation 8.62	-0.1 Letters Standard Deviation 7.78
Change From Baseline in Visual Acuity (VA): Open Phase Week 36	4.4 Letters Standard Deviation 8.43	0.6 Letters Standard Deviation 7.91
Change From Baseline in Visual Acuity (VA): Open Phase Week 42	4.3 Letters Standard Deviation 8.27	0.3 Letters Standard Deviation 8.86
Change From Baseline in Visual Acuity (VA): Open Phase Week 48	4.1 Letters Standard Deviation 8.52	-0.8 Letters Standard Deviation 10.09
Change From Baseline in Visual Acuity (VA): Open Phase Week 54	3.6 Letters Standard Deviation 8.93	-0.5 Letters Standard Deviation 10.48

SECONDARY outcome

Timeframe: Weeks 24 to 54

Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase Focal/Grid Laser	3 Participants	3 Participants
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase Vitrectomy	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase Baseline	56.8 Letters Standard Deviation 8.39	56.9 Letters Standard Deviation 8.15
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase Week 6	59.5 Letters Standard Deviation 8.24	57.1 Letters Standard Deviation 10.29
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase Week 12	60.0 Letters Standard Deviation 9.32	56.4 Letters Standard Deviation 11.65
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase Week 18	59.7 Letters Standard Deviation 9.66	57.1 Letters Standard Deviation 11.52
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase Week 24	59.9 Letters Standard Deviation 9.89	55.7 Letters Standard Deviation 12.18

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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	4 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 6: Lost 10 - 14 Letters	0 Participants	2 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 6: Lost 1 - 9 Letters	33 Participants	40 Participants
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	71 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 6: Gained 10 - 14 Letters	12 Participants	3 Participants
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	0 Participants
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	5 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 12: Lost 10 - 14 Letters	1 Participants	3 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 12: Lost 1 - 9 Letters	28 Participants	50 Participants
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	54 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 12: Gained 10 - 14 Letters	12 Participants	7 Participants
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	1 Participants
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	4 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 18: Lost 10 - 14 Letters	3 Participants	3 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 18: Lost 1 - 9 Letters	33 Participants	43 Participants
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	62 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 18: Gained 10 - 14 Letters	15 Participants	6 Participants
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	2 Participants
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	9 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 24: Lost 10 - 14 Letters	6 Participants	5 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 24: Lost 1 - 9 Letters	30 Participants	41 Participants
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	59 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase Week 24: Gained 10 - 14 Letters	18 Participants	5 Participants
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	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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	3 Participants
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	8 Participants
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	8 Participants
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	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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	1 Participants
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	31 Participants
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	65 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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	25 Participants
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	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=123 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=120 Participants 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.
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 18.80	-2.1 Units on a scale Standard Deviation 20.56
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 17.80	0.7 Units on a scale Standard Deviation 19.20
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	0.6 Units on a scale Standard Deviation 18.77
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	0.6 Units on a scale Standard Deviation 18.60
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	-1.3 Units on a scale Standard Deviation 15.80
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	-1.7 Units on a scale Standard Deviation 17.13
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	-0.5 Units on a scale Standard Deviation 17.91
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	-1.1 Units on a scale Standard Deviation 21.72
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	-1.1 Units on a scale Standard Deviation 18.38
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	-5.7 Units on a scale Standard Deviation 20.84
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	-0.9 Units on a scale Standard Deviation 19.85
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	-4.1 Units on a scale Standard Deviation 21.26
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	-1.1 Units on a scale Standard Deviation 10.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
Mean Visual Acuity Over Time at Each Time Point: Open Phase Baseline	57.2 Letters Standard Deviation 8.07	56.7 Letters Standard Deviation 8.28
Mean Visual Acuity Over Time at Each Time Point: Open Phase Week 30	60.7 Letters Standard Deviation 10.52	56.6 Letters Standard Deviation 11.25
Mean Visual Acuity Over Time at Each Time Point: Open Phase Week 36	61.6 Letters Standard Deviation 10.47	57.3 Letters Standard Deviation 11.59
Mean Visual Acuity Over Time at Each Time Point: Open Phase Week 42	61.5 Letters Standard Deviation 10.01	57.0 Letters Standard Deviation 12.24
Mean Visual Acuity Over Time at Each Time Point: Open Phase Week 48	61.3 Letters Standard Deviation 10.11	55.9 Letters Standard Deviation 13.61
Mean Visual Acuity Over Time at Each Time Point: Open Phase Week 54	60.8 Letters Standard Deviation 10.63	56.2 Letters Standard Deviation 13.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 30, 36, 42, 48, and 54

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 54: Gained 10 - 14 Letters	15 Participants	13 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 42: Gained 10 - 14 Letters	16 Participants	12 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 48: Lost 1 - 9 Letters	27 Participants	24 Participants
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	54 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 54: Gained 15 Letters or More	13 Participants	2 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 30: Lost 15 Letters or More	4 Participants	8 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 30: Lost 10 - 14 Letters	2 Participants	5 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 30: Lost 1 - 9 Letters	31 Participants	31 Participants
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	61 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 30: Gained 10 - 14 Letters	15 Participants	7 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 30: Gained 15 Letters or More	11 Participants	0 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 36: Lost 15 Letters or More	3 Participants	6 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 36: Lost 10 - 14 Letters	1 Participants	8 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 36: Lost 1 - 9 Letters	22 Participants	25 Participants
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	63 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 36: Gained 10 - 14 Letters	13 Participants	10 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 36: Gained 15 Letters or More	13 Participants	0 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 42: Lost 15 Letters or More	2 Participants	8 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 42: Lost 10 - 14 Letters	2 Participants	10 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 42: Lost 1 - 9 Letters	24 Participants	26 Participants
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	53 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 42: Gained 15 Letters or More	13 Participants	3 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 48: Lost 15 Letters or More	2 Participants	13 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 48: Lost 10 - 14 Letters	5 Participants	9 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 48: Gained 10 - 14 Letters	15 Participants	9 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 48: Gained 15 Letters or More	16 Participants	3 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 54: Lost 15 Letters or More	3 Participants	10 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 54: Lost 10 - 14 Letters	3 Participants	10 Participants
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase Week 54: Lost 1 - 9 Letters	27 Participants	28 Participants
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	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
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	15 Participants
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	7 Participants
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	10 Participants
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	15 Participants
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	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
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	2 Participants
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	40 Participants
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	64 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
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	16 Participants
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	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 54

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=116 Participants 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).	Sham in Double Masked, Then Pegaptanib Sodium in Open Phase n=112 Participants 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.
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	-0.5 Units on a scale Standard Deviation 15.46
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	-2.5 Units on a scale Standard Deviation 17.25
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	-2.7 Units on a scale Standard Deviation 20.43
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	0.7 Units on a scale Standard Deviation 17.96
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	-1.8 Units on a scale Standard Deviation 20.52
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	0.0 Units on a scale Standard Deviation 17.35
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	-0.6 Units on a scale Standard Deviation 19.92
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	-0.6 Units on a scale Standard Deviation 20.90
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 19.30	-3.3 Units on a scale Standard Deviation 18.76
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	-7.2 Units on a scale Standard Deviation 26.03
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 15.00	-2.8 Units on a scale Standard Deviation 18.43
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 22.20	-3.4 Units on a scale Standard Deviation 22.07
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	-1.8 Units on a scale Standard Deviation 11.16

Adverse Events

Pegaptanib Sodium (Baseline to Week 24)

Serious events: 10 serious events

Other events: 72 other events

Deaths: 0 deaths

Sham (Baseline to Week 24)

Serious events: 10 serious events

Other events: 53 other events

Deaths: 0 deaths

Pegaptanib Sodium (Baseline to Week 54)

Serious events: 19 serious events

Other events: 83 other events

Deaths: 0 deaths

Sham Conversion (Week 24 to Week 54)

Serious events: 7 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pegaptanib Sodium (Baseline to Week 24) n=123 participants at risk 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).	Sham (Baseline to Week 24) n=120 participants at risk 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 (Baseline to Week 54) n=123 participants at risk 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).	Sham Conversion (Week 24 to Week 54) n=112 participants at risk 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.
Eye disorders Conjunctival Haemorrhage	43.9% 54/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	27.5% 33/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.3% 57/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 4/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival Oedema	9.8% 12/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.8% 13/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.8% 12/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Corneal Erosion	2.4% 3/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.2% 5/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.5% 8/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 2/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Diabetic Retinal Oedema	5.7% 7/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 4/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.6% 13/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.8% 11/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye pain	7.3% 9/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 1/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 11/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.89% 1/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Punctate Keratitis	9.8% 12/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.8% 7/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.8% 17/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 7/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	12.2% 15/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.2% 11/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	22.0% 27/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 10/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Intraocular Pressure Increased	6.5% 8/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.6% 18/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 10/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival hyperaemia	1.6% 2/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.8% 7/120 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 2/123 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/112 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER