CClinicalTrials.gg
Sign In
CompletedNCT00239928Updated May 12, 2011Results posted

Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

A Phase 2 interventional study of pegaptanib sodium in Macular Degeneration, sponsored by Pfizer. Completed at 12 sites in Japan. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2011-05-12.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
51 Years and older
Sex
All
01

Study summary

This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).

02

Conditions studied

  • Macular Degeneration

Keywords

  • Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 61 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • After completion of the preceding study (A5751010)

Exclusion criteria

Exclusion Criteria:

  • Serious heart, kidney and/or liver disease
  • Diabetic retinopathy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    EYE001

    Drug: pegaptanib sodium

Interventions

  • Drugpegaptanib sodium

    1 drop per dosed eye per protocol.

06

What researchers measure

Primary outcomes

  1. Summary of Adverse Events

    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

    Time frame: Week 54 (initiation of A5751015 study) up to Week 198

Secondary outcomes

  1. Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point

    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.

    Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  2. Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point

    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.

    Time frame: Weeks 54, every 18 weeks from Week 54 up to Week 198

  3. Number of Responders

    Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.

    Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  4. Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)

    Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.

    Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  5. Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)

    Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.

    Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  6. Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)

    Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.

    Time frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

07

Results

Posted May 4, 2011

Participant flow

Participant flow — Overall Study
MilestoneEYE001
Started61
Completed51
Not completed10
Withdrew: Lack of efficacy1
Withdrew: Adverse event4
Withdrew: Not need to continue study3
Withdrew: Withdrawal by subject2

Outcome measures

SecondaryMean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point

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.

Time frame:
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Reported as:
Mean · letters
Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point
lettersEYE001
Week 54-3.2 ± 13.36
Week 72-3.3 ± 15.25
Week 90-4.7 ± 15.97
Week 108-8.6 ± 16.83
Week 126-8.6 ± 18.36
Week 144-10.1 ± 17.95
Week 162-10.4 ± 16.70
Week 180-10.4 ± 16.63
Week 198-10.3 ± 16.42
SecondaryMean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point

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.

Time frame:
Weeks 54, every 18 weeks from Week 54 up to Week 198
Reported as:
Mean · letters
Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point
lettersEYE001
Week 72-0.1 ± 6.72
Week 90-1.4 ± 9.63
Week 108-4.8 ± 11.69
Week 126-4.5 ± 13.25
Week 144-6.1 ± 13.45
Week 162-6.3 ± 12.99
Week 180-6.3 ± 12.77
Week 198-6.2 ± 12.92
SecondaryNumber of Responders

Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.

Time frame:
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Reported as:
Number · participants
Number of Responders
participantsEYE001
Week 5441
Week 7241
Week 9037
Week 10833
Week 12632
Week 14430
Week 16229
Week 18029
Week 19830
SecondaryNumber of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)

Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.

Time frame:
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Reported as:
Number · participants
Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)
participantsEYE001
Week 544
Week 727
Week 907
Week 1086
Week 1266
Week 1445
Week 1626
Week 1805
Week 1985
SecondaryNumber of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)

Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.

Time frame:
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Reported as:
Number · participants
Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)
participantsEYE001
Week 5424
Week 7220
Week 9021
Week 10816
Week 12617
Week 14415
Week 16215
Week 18015
Week 19815
SecondaryNumber of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)

Subjects with severe vision loss: loss from baseline of \>= 30 letters of visual acuity.

Time frame:
Week 0 (baseline), every 18 weeks from Week 54 up to Week 198
Reported as:
Number · participants
Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)
participantsEYE001
Week 540
Week 721
Week 904
Week 1087
Week 1266
Week 1447
Week 1626
Week 1807
Week 1987
PrimarySummary of Adverse Events

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

Time frame:
Week 54 (initiation of A5751015 study) up to Week 198
Reported as:
Number · participants
Summary of Adverse Events
participantsEYE001
Subjects with adverse events57
Subjects with serious adverse events16
Subjects with ophthalmic adverse event47
Subjects with severe adverse events4
Severe Myocardial Infarction1
Severe Femur Fracture1
Severe Gastric Cancer1
Severe Pancreatic Carcinoma1
Subjects discontinued due to adverse events4
Subjects with dose reduction or temporary disconti4

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EYE001—16/61 (26.2%)43/61 (70.5%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventEYE001
Macular degenerationEye disorders3/61
Angina pectorisCardiac disorders1/61
Myocardial infarctionCardiac disorders1/61
CataractEye disorders1/61
Colonic polypGastrointestinal disorders1/61
Gastric polypsGastrointestinal disorders1/61
HaemorrhoidsGastrointestinal disorders1/61
PyrexiaGeneral disorders1/61
Herpes zosterInfections and infestations1/61
PneumoniaInfections and infestations1/61
Most frequent other events
Showing 10 of 11
Most frequent other events
EventEYE001
NasopharyngitisInfections and infestations17/61
Conjunctival hemorrhageEye disorders14/61
KeratitisEye disorders11/61
Conjunctival hyperaemiaEye disorders10/61
Eye painEye disorders9/61
ConjunctivitisEye disorders8/61
Corneal erosionEye disorders7/61
Visual acuity reducedEye disorders7/61
MyodesopsiaEye disorders5/61
Retinal haemorrhageEye disorders5/61

Baseline characteristics

Age, Customized
Age, Customized(participants)EYE001
< 18 years0
18-64 years7
>=65 years54
Age Continuous
Age Continuous(years)EYE001
Mean73.3 ± 8.1
Sex: Female, Male
Sex: Female, Male(Participants)EYE001
Female10
Male51
Region of Enrollment
Region of Enrollment(participants)EYE001
Japan61
08

Study locations

12 sites
  • Pfizer Investigational Site
    Nagoya, Aichi, Japan
  • Pfizer Investigational Site
    Urayasu, Chiba, Japan
  • Pfizer Investigational Site
    Fukuoka-shi, Fukuoka-ken, Japan
  • Pfizer Investigational Site
    Maebashi, Gunma, Japan
  • Pfizer Investigational Site
    Sapporo, Hokkaido, Japan
  • Pfizer Investigational Site
    Moriguchi, Osaka, Japan
  • Pfizer Investigational Site
    Suita, Osaka, Japan
  • Pfizer Investigational Site
    Otsu, Shiga, Japan
  • Pfizer Investigational Site
    Chiyoda-ku, Tokyo, Japan
  • Pfizer Investigational Site
    Shinjuku-ku, Tokyo, Japan
  • Pfizer Investigational Site
    Fukushima, Japan
  • Pfizer Investigational Site
    Kyoto, Japan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00239928
Lead sponsor
Pfizer
First posted
Oct 17, 2005
Start date
Sep 2005
Primary completion
Nov 2008
Completion
Nov 2008
Results posted
May 4, 2011
Last update
May 12, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Macular Degeneration→

Other studies from this sponsor

Pfizer

Start the discussion