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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01100307
First received: April 7, 2010
Last updated: August 16, 2013
Last verified: May 2013

April 7, 2010
August 16, 2013
May 2010
August 2012   (final data collection date for primary outcome measure)
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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
The proportion of subjects who experience a ≥ 10 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01100307 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Visual Acuity (VA): Double Masked Phase [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts
  • Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
  • 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 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • Change From Baseline in Visual Acuity (VA): Open Phase [ Time Frame: Baseline, Weeks 30, 36, 42, 48 and 54 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase [ Time Frame: Weeks 24 to 54 ] [ Designated as safety issue: No ]
    Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
  • Mean change of VA over time [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects underwent focal or grid laser [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects underwent vitrectomy [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • Mean VA over time and distribution of mean VA at each time point [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who experience a ≥ 10 letter improvement of visual acuity in ETDRS chart from baseline over time [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who experience a ≥ 15 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who experience a ≥ 5 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who experience a ≥ 0 letter improvement of visual acuity in ETDRS chart from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects exhibiting a decrease in retinal thickness at the center point by 25% and 50% using OCT [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • The mean change in NEI-VFQ 25 scores from baseline [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]
  • Adverse Events, Serious Adverse Events, Laboratory events [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: Yes ]
  • Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

    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.

  • 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 [ Time Frame: Baseline, Weeks 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • 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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • 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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

    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.

  • Mean Visual Acuity Over Time at Each Time Point: Open Phase [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ] [ Designated as safety issue: No ]

    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.

  • Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase [ Time Frame: Baseline, Weeks 30, 36, 42, 48, and 54 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • 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 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
  • 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 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]

    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.

Not Provided
 
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
A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)

The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Macular Edema
  • Diabetic Mellitus
  • Retinal Disease
  • Drug: pegaptanib sodium
    Intravitreal injection of 0.3 mg every 6 weeks
  • Other: sham injection
    sham injection every 6 weeks
  • Experimental: pegaptanib sodium
    Intervention: Drug: pegaptanib sodium
  • Sham Comparator: sham injection
    Intervention: Other: sham injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type I, or Type II diabetic subjects
  • Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive

Exclusion Criteria:

  • Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
  • HbA1C level >12% or recent signs of uncontrolled diabetes
  • Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01100307
A5751034
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP