NCT00324116

Brief Summary

To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 2, 2009

Completed
Last Updated

March 23, 2010

Status Verified

March 1, 2010

Enrollment Period

2.1 years

First QC Date

May 8, 2006

Results QC Date

August 25, 2009

Last Update Submit

March 15, 2010

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)

    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.

    Baseline, 54 Weeks

Secondary Outcomes (6)

  • Change From Baseline in Visual Acuity

    Baseline, 6 weeks, 12 weeks, 54 weeks

  • Number of Subjects Gaining Vision

    54 weeks or at early termination

  • Number of Subjects Maintaining Vision

    54 weeks or at early termination

  • Number of Subjects With Severe Visual Loss

    54 weeks or at early termination

  • Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)

    54 weeks

  • +1 more secondary outcomes

Study Arms (1)

Active

EXPERIMENTAL
Drug: pegaptanib sodium (Macugen)

Interventions

pegaptanib sodium (Macugen)DRUG

0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.

Also known as: MACUGEN
Active

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
  • Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
  • Women must be using 2 forms of effective contraception
  • Adequate hematological, renal and liver functions

You may not qualify if:

  • Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
  • Any extrafoveal choroidal neovascularization
  • Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
  • Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
  • Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Pfizer Investigational Site

Angers, Cedex 09, 49933, France

Location

Pfizer Investigational Site

Lyon, Cedex 4, 69317, France

Location

Pfizer Investigational Site

Besançon, Cedex, 25030, France

Location

Pfizer Investigational Site

Créteil, Cedex, 94010, France

Location

Pfizer Investigational Site

Mâcon, Cedex, 71018, France

Location

Pfizer Investigational Site

Poitiers, Cedex, 86021, France

Location

Pfizer Investigational Site

Bayonne, 64100, France

Location

Pfizer Investigational Site

Belfort, 90016, France

Location

Pfizer Investigational Site

Bordeaux, 33076, France

Location

Pfizer Investigational Site

Bordeaux, 33100, France

Location

Pfizer Investigational Site

Brest, 29200, France

Location

Pfizer Investigational Site

Dijon, 21033, France

Location

Pfizer Investigational Site

La Rochefoucauld, 16110, France

Location

Pfizer Investigational Site

La Tronche, 38700, France

Location

Pfizer Investigational Site

Lille, 59800, France

Location

Pfizer Investigational Site

Limoges, 87042, France

Location

Pfizer Investigational Site

Lyon, 69003, France

Location

Pfizer Investigational Site

Marseille, 13008, France

Location

Pfizer Investigational Site

Montpellier, 34000, France

Location

Pfizer Investigational Site

Montpellier, 34070, France

Location

Pfizer Investigational Site

Mulhouse, 68070, France

Location

Pfizer Investigational Site

Nancy, 54000, France

Location

Pfizer Investigational Site

Nantes, 44093, France

Location

Pfizer Investigational Site

Paris, 75006, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Paris, 75557, France

Location

Pfizer Investigational Site

Paris, 75940, France

Location

Pfizer Investigational Site

Rives, 38140, France

Location

Pfizer Investigational Site

Rouen, 76000, France

Location

Pfizer Investigational Site

Saint-Herblain, 44819, France

Location

Pfizer Investigational Site

Strasbourg, 67000, France

Location

Pfizer Investigational Site

Strasbourg, 67091, France

Location

Pfizer Investigational Site

Toulouse, 31054, France

Location

Pfizer Investigational Site

Toulouse, 31200, France

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 10, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 23, 2010

Results First Posted

October 2, 2009

Record last verified: 2010-03

Locations

FR(34)