Trial Outcomes & Findings for Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration (NCT NCT00239928)
NCT ID: NCT00239928
Last Updated: 2011-05-12
Results Overview
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
COMPLETED
PHASE2
61 participants
Week 54 (initiation of A5751015 study) up to Week 198
2011-05-12
Participant Flow
All subjects received a 0.3 mg or 1 mg/eye EYE001 (pegaptanib sodium) intravitreal injection every 6 weeks for 48 weeks in the preceding study A5751010 (NCT00150202)
Participant milestones
| Measure |
EYE001
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
EYE001
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Not need to continue study
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
EYE001
n=61 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Age, Customized
< 18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
7 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
54 participants
n=5 Participants
|
|
Age Continuous
|
73.3 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 54 (initiation of A5751015 study) up to Week 198Population: Intent-to-treat
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
Outcome measures
| Measure |
EYE001
n=61 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Summary of Adverse Events
Subjects with adverse events
|
57 participants
|
|
Summary of Adverse Events
Subjects with serious adverse events
|
16 participants
|
|
Summary of Adverse Events
Subjects with ophthalmic adverse event
|
47 participants
|
|
Summary of Adverse Events
Subjects with severe adverse events
|
4 participants
|
|
Summary of Adverse Events
Severe Myocardial Infarction
|
1 participants
|
|
Summary of Adverse Events
Severe Femur Fracture
|
1 participants
|
|
Summary of Adverse Events
Severe Gastric Cancer
|
1 participants
|
|
Summary of Adverse Events
Severe Pancreatic Carcinoma
|
1 participants
|
|
Summary of Adverse Events
Subjects discontinued due to adverse events
|
4 participants
|
|
Summary of Adverse Events
Subjects with dose reduction or temporary disconti
|
4 participants
|
SECONDARY outcome
Timeframe: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat. Last Observation Carried Forward
Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Outcome measures
| Measure |
EYE001
n=53 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 54
|
-3.2 letters
Standard Deviation 13.36
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 72
|
-3.3 letters
Standard Deviation 15.25
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 90
|
-4.7 letters
Standard Deviation 15.97
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 108
|
-8.6 letters
Standard Deviation 16.83
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 126
|
-8.6 letters
Standard Deviation 18.36
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 144
|
-10.1 letters
Standard Deviation 17.95
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 162
|
-10.4 letters
Standard Deviation 16.70
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 180
|
-10.4 letters
Standard Deviation 16.63
|
|
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
Week 198
|
-10.3 letters
Standard Deviation 16.42
|
SECONDARY outcome
Timeframe: Weeks 54, every 18 weeks from Week 54 up to Week 198Population: Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72. Last Observation Carried Forward
Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
Outcome measures
| Measure |
EYE001
n=61 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 72
|
-0.1 letters
Standard Deviation 6.72
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 90
|
-1.4 letters
Standard Deviation 9.63
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 108
|
-4.8 letters
Standard Deviation 11.69
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 126
|
-4.5 letters
Standard Deviation 13.25
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 144
|
-6.1 letters
Standard Deviation 13.45
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 162
|
-6.3 letters
Standard Deviation 12.99
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 180
|
-6.3 letters
Standard Deviation 12.77
|
|
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
Week 198
|
-6.2 letters
Standard Deviation 12.92
|
SECONDARY outcome
Timeframe: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat. Last Observation Carried Forward
Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
Outcome measures
| Measure |
EYE001
n=53 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Number of Responders
Week 54
|
41 participants
|
|
Number of Responders
Week 72
|
41 participants
|
|
Number of Responders
Week 90
|
37 participants
|
|
Number of Responders
Week 108
|
33 participants
|
|
Number of Responders
Week 126
|
32 participants
|
|
Number of Responders
Week 144
|
30 participants
|
|
Number of Responders
Week 162
|
29 participants
|
|
Number of Responders
Week 180
|
29 participants
|
|
Number of Responders
Week 198
|
30 participants
|
SECONDARY outcome
Timeframe: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat. Last Observation Carried Forward
Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
Outcome measures
| Measure |
EYE001
n=53 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 54
|
4 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 72
|
7 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 90
|
7 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 108
|
6 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 126
|
6 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 144
|
5 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 162
|
6 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 180
|
5 participants
|
|
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
Week 198
|
5 participants
|
SECONDARY outcome
Timeframe: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat. Last Observation Carried Forward
Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
Outcome measures
| Measure |
EYE001
n=53 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 54
|
24 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 72
|
20 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 90
|
21 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 108
|
16 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 126
|
17 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 144
|
15 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 162
|
15 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 180
|
15 participants
|
|
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
Week 198
|
15 participants
|
SECONDARY outcome
Timeframe: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198Population: Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat. Last Observation Carried Forward
Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.
Outcome measures
| Measure |
EYE001
n=53 Participants
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 54
|
0 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 72
|
1 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 90
|
4 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 108
|
7 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 126
|
6 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 144
|
7 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 162
|
6 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 180
|
7 participants
|
|
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
Week 198
|
7 participants
|
Adverse Events
EYE001
Serious adverse events
| Measure |
EYE001
n=61 participants at risk
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Eye disorders
Macular degeneration
|
4.9%
3/61 • Number of events 3
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/61 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/61 • Number of events 1
|
|
Eye disorders
Cataract
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Gastric polyps
|
1.6%
1/61 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pyrexia
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
1.6%
1/61 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.6%
1/61 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm
|
1.6%
1/61 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis obliterans
|
1.6%
1/61 • Number of events 1
|
Other adverse events
| Measure |
EYE001
n=61 participants at risk
All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
|
|---|---|
|
Eye disorders
Conjunctival hemorrhage
|
23.0%
14/61 • Number of events 14
|
|
Eye disorders
Conjunctival hyperaemia
|
16.4%
10/61 • Number of events 10
|
|
Eye disorders
Conjunctivitis
|
13.1%
8/61 • Number of events 8
|
|
Eye disorders
Corneal erosion
|
11.5%
7/61 • Number of events 7
|
|
Eye disorders
Eye pain
|
14.8%
9/61 • Number of events 9
|
|
Eye disorders
Keratitis
|
18.0%
11/61 • Number of events 11
|
|
Eye disorders
Visual acuity reduced
|
11.5%
7/61 • Number of events 7
|
|
Eye disorders
Myodesopsia
|
8.2%
5/61 • Number of events 5
|
|
Eye disorders
Punctate keratitis
|
6.6%
4/61 • Number of events 4
|
|
Eye disorders
Retinal haemorrhage
|
8.2%
5/61 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
27.9%
17/61 • Number of events 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days.Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites.Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER