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OpenTrials
Completed

NCT Number: NCT01100307

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

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.

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Key information

Conditions

Macular Edema Diabetic Mellitus Eye Diseases Macular Degeneration Retinal Degeneration Retinal Disease Retinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya City University Hospital, Nagoya, Aichi-ken, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegaptanib sodium

Drug

Intravitreal injection of 0.3 mg every 6 weeks

Sham Injection

Other

sham injection every 6 weeks

Primary outcomes

  1. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Secondary outcomes

  1. Change From Baseline in Visual Acuity (VA): Double Masked Phase

    Time frame: Baseline, Weeks 6, 12, 18, and 24

    Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts

  2. Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase

    Time frame: Up to 24 weeks

    Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

  3. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  4. Change From Baseline in Visual Acuity (VA): Open Phase

    Time frame: Baseline, Weeks 30, 36, 42, 48 and 54

    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.

  5. Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase

    Time frame: Weeks 24 to 54

    Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Other outcomes

  1. Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase

    Time frame: Baseline, Weeks 6, 12, 18, and 24

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  2. 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

    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.

  3. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  4. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  5. 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

    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.

  6. 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

    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.

  7. Mean Visual Acuity Over Time at Each Time Point: Open Phase

    Time frame: Baseline, Weeks 30, 36, 42, 48, and 54

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  8. 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

    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.

  9. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  10. 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

    Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  11. 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

    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.

  12. 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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2010
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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