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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Retinal Disease; Diabetic Mellitus
• Intervention / Treatment: Drug: pegaptanib sodium; Other: sham injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan
    • Akita University Hospital
  • Aomori, Japan
    • Aomori Prefectural Chuo Hospital
  • Chiba, Japan
    • Chiba University Hospital
  • Fukuoka, Japan
    • Kyushu University Hospital
  • Fukuoka, Japan
    • Hayashi Eye Hospital
  • Fukuoka, Japan
    • Murakami Karindo Hospital
  • Fukuoka, Japan
    • Ohshima Hospital of Ophthalmology
  • Fukushima, Japan
    • Fukushima Medical University Hospital
  • Kagoshima, Japan
    • Kagoshima University Hospital
  • Kumamoto, Japan
    • Ideta Eye Hospital
  • Kyoto, Japan
    • Kyoto University Hospital
  • Niigata, Japan
    • Niigata University Medical And Dental Hospital
  • Osaka, Japan
    • Osaka General Medical Center
  • Osaka, Japan
    • Osaka City University Hospital
  • Osaka, Japan
    • Osaka Saiseikai Izou Hospital
  • Saga, Japan
    • Saga Prefectural Hospital Koseikan
  • Aichi
    • Nagoya, Aichi, Japan
      • National Hospital Organization Nagoya Medical Center
    • Nagoya, Aichi, Japan
      • Nagoya University Hospital
    • Nagoya, Aichi, Japan
      • Nagoya City University Hospital
  • Chiba-Ken
    • Urayasu-shi, Chiba-Ken, Japan
      • Juntendo University Hospital Urayasu, Ophthalmology
  • Fukuoka
    • Kurume, Fukuoka, Japan
      • St. Mary's Hospital
  • Gumma
    • Maebashi, Gumma, Japan
      • Gunma University Hospital
  • Hiroshima
    • Kure, Hiroshima, Japan
      • Kimura Eye & Internal Medicine Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
      • Asahikawa Medical College Hospital
    • Hakodate, Hokkaido, Japan
      • Yoshida Eye Hospital
    • Sapporo, Hokkaido, Japan
      • Hokkaido University Hospital
  • Hyogo
    • Amagasaki, Hyogo, Japan
      • Hyogo Prefectural Amagasaki Hospital
    • Kobe, Hyogo, Japan
      • Kobe City Medical Center General Hospital
    • Kobe, Hyogo, Japan
      • Kohnan Hospital
  • Ibaraki
    • Hitachi, Ibaraki, Japan
      • Hitachi General Hospital
    • Mito, Ibaraki, Japan
      • Mito Kyodo General Hospital
  • Kagawa
    • Kida-gun, Kagawa, Japan
      • Kagawa University Hospital
  • Miyagi
    • Sendai, Miyagi, Japan
      • NTT East Tohoku Hospital
  • Nagano
    • Matsumoto, Nagano, Japan
      • Shinshu University Hospital
  • Nara
    • Kashihara, Nara, Japan
      • Nara Medical University Hospital
  • Osaka
    • Osaka-sayama-shi, Osaka, Japan
      • Kinki University Hospital, Anesthesiology
  • Shiga
    • Otsu, Shiga, Japan
      • Shiga University of Medical Science Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
      • Seirei Hamamatsu General Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan
      • Ochanomizu Inoue Eye Clinic
    • Chiyoda-ku, Tokyo, Japan
      • Nihon University Surugadai Hospital
    • Meguro-ku, Tokyo, Japan
      • National Hospital Organization Tokyo Medical Center
    • Shinjuku-ku, Tokyo, Japan
      • Keio University Hospital
  • Yamaguchi
    • Shunan, Yamaguchi, Japan
      • Hirota Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham injection	Other: sham injection; sham injection every 6 weeks
Experimental: pegaptanib sodium	Drug: pegaptanib sodium; Intravitreal injection of 0.3 mg every 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Visual Acuity (VA): Double Masked Phase	Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts	Baseline, Weeks 6, 12, 18, and 24
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase	Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.	Up to 24 weeks
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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 54
Change From Baseline in Visual Acuity (VA): Open Phase	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.	Baseline, Weeks 30, 36, 42, 48 and 54
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase	Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.	Weeks 24 to 54

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 6, 12, 18, and 24
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase	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.	Baseline, Weeks 6, 12, 18, and 24
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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 6, 12, 18, and 24
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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 24
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	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.	Baseline and Week 24
Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase	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.	Baseline and Week 24
Mean Visual Acuity Over Time at Each Time Point: Open Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 30, 36, 42, 48, and 54
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase	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.	Baseline, Weeks 30, 36, 42, 48, and 54
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 30, 36, 42, 48, and 54
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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 54
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	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.	Baseline and Week 54
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	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.	Baseline and Week 54

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: diabetic macular edema; Macugen; sham-controlled study
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Macular Degeneration; Retinal Diseases; Macular Edema; Edema
• Other Study ID Numbers: A5751034