Trial Outcomes & Findings for Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions (NCT NCT00324116)

Last Updated: 2010-03-23

Results Overview

Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

Baseline, 54 Weeks

Results posted on

2010-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Study STARTED	81
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	17
Overall Study Withdrawal by Subject	5
Overall Study Other	5

Baseline Characteristics

Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegaptanib Sodium n=81 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Age Continuous	76.3 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 54 Weeks

Population: The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Censored (subjects with missing data)	33 participants
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Responders	40 participants Interval 76.0 to 95.0
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Non-Responders	7 participants

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, 54 weeks

Population: FAS; n=number of subjects with evaluable data.

Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Change From Baseline in Visual Acuity 6 weeks (n=76)	-4.29 score on scale Standard Deviation 11.11
Change From Baseline in Visual Acuity 12 weeks (n=74)	-5.86 score on scale Standard Deviation 13.79
Change From Baseline in Visual Acuity 54 weeks (n=49)	-11.12 score on scale Standard Deviation 17.96

SECONDARY outcome

Timeframe: 54 weeks or at early termination

Population: FAS

Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Number of Subjects Gaining Vision Gained	4 participant
Number of Subjects Gaining Vision Did not gain	74 participant
Number of Subjects Gaining Vision Assessment Not Done	2 participant

SECONDARY outcome

Timeframe: 54 weeks or at early termination

Population: FAS

Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Number of Subjects Maintaining Vision Maintained	18 participants
Number of Subjects Maintaining Vision Did not maintain	60 participants
Number of Subjects Maintaining Vision Not Done	2 participants

SECONDARY outcome

Timeframe: 54 weeks or at early termination

Population: FAS

Subjects with severe visual loss: loss from baseline of \>= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Number of Subjects With Severe Visual Loss Not severe loss	67 participants
Number of Subjects With Severe Visual Loss Severe Loss	11 participants
Number of Subjects With Severe Visual Loss Not Done	2 participants

SECONDARY outcome

Timeframe: 54 weeks

Population: FAS; n=77 (number of Subjects at Baseline with \>20/200 Visual Acuity)

Subjects with improving scores are those with \> 20/200 at Baseline and progressing to =\< 20/200 at Week 54. Subjects with no change are those with \> 20/200 at Baseline and remaining at \> 20/200 at Week 54.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) Improved	20 participants
Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) No Change	57 participants

SECONDARY outcome

Timeframe: Baseline, 54 weeks or at early termination

Population: FAS; n=number of subjects with evaluable data.

Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.

Outcome measures

Outcome measures
Measure	Pegaptanib Sodium n=80 Participants All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Composite (n=25)	-2.25 score on scale Standard Deviation 15.71
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). General Health (n=42)	-4.17 score on scale Standard Deviation 14.52
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). General Vision (n=41)	3.90 score on scale Standard Deviation 16.26
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Ocular Pain (n=43)	0.35 score on scale Standard Deviation 15.29
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Near Vision Activities (n=43)	-3.88 score on scale Standard Deviation 27.60
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Distance Vision Activities (n=43)	-6.78 score on scale Standard Deviation 23.68
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Social Functioning (n=43)	-0.58 score on scale Standard Deviation 24.84
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Mental Health Activities (n=43)	-0.30 score on scale Standard Deviation 20.45
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Role Difficulties (n=41)	-4.39 score on scale Standard Deviation 26.46
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Dependency (n=41)	-5.28 score on scale Standard Deviation 22.15
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Driving (n=27)	-3.70 score on scale Standard Deviation 30.67
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Color Vision (n=41)	-1.83 score on scale Standard Deviation 18.87
Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). Peripheral Vision (n=42)	-4.17 score on scale Standard Deviation 25.25

Adverse Events

Pegaptanib Sodium

Serious events: 8 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Cardiac disorders Cardiac failure	1.2% 1/81
Cardiac disorders Cardiac failure acute	1.2% 1/81
Eye disorders Cataract operation	1.2% 1/81
Eye disorders Macular degeneration	1.2% 1/81
Gastrointestinal disorders Peritonitis	1.2% 1/81
Infections and infestations Pyelonephritis	1.2% 1/81
Cardiac disorders Angina unstable	1.2% 1/81
Eye disorders Retinal haemorrhage	1.2% 1/81
Psychiatric disorders Suicide attempt	1.2% 1/81

Other adverse events

Other adverse events
Measure	Pegaptanib Sodium All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
Eye disorders Conjunctival haemorrhage	7.4% 6/81
Eye disorders Eye pain	8.6% 7/81
Eye disorders Macular degeneration	9.9% 8/81
Eye disorders Myodesopsia	14.8% 12/81
General disorders Pain	6.2% 5/81

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 \< 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 information other than study results.
Publication restrictions are in place

Restriction type: OTHER