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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

Primary Purpose

Macular Edema, Diabetic Mellitus, Retinal Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
pegaptanib sodium
sham injection
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring diabetic macular edema, Macugen, sham-controlled study

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya City University Hospital
  • Nagoya University Hospital
  • National Hospital Organization Nagoya Medical Center
  • Juntendo University Hospital Urayasu, Ophthalmology
  • St. Mary's Hospital
  • Gunma University Hospital
  • Kimura Eye & Internal Medicine Hospital
  • Asahikawa Medical College Hospital
  • Yoshida Eye Hospital
  • Hokkaido University Hospital
  • Hyogo Prefectural Amagasaki Hospital
  • Kobe City Medical Center General Hospital
  • Kohnan Hospital
  • Hitachi General Hospital
  • Mito Kyodo General Hospital
  • Kagawa University Hospital
  • NTT East Tohoku Hospital
  • Shinshu University Hospital
  • Nara Medical University Hospital
  • Kinki University Hospital, Anesthesiology
  • Shiga University of Medical Science Hospital
  • Seirei Hamamatsu General Hospital
  • Nihon University Surugadai Hospital
  • Ochanomizu Inoue Eye Clinic
  • National Hospital Organization Tokyo Medical Center
  • Keio University Hospital
  • Hirota Eye Clinic
  • Akita University Hospital
  • Aomori Prefectural Chuo Hospital
  • Chiba University Hospital
  • Hayashi Eye Hospital
  • Kyushu University Hospital
  • Murakami Karindo Hospital
  • Ohshima Hospital of Ophthalmology
  • Fukushima Medical University Hospital
  • Kagoshima University Hospital
  • Ideta eye hospital
  • Kyoto University Hospital
  • Niigata University Medical and Dental Hospital
  • Osaka City University Hospital
  • Osaka general medical center
  • Osaka Saiseikai Izou Hospital
  • Saga Prefectural Hospital Koseikan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

pegaptanib sodium

sham injection

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
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
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
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
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Full Information

First Posted
April 7, 2010
Last Updated
August 16, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01100307
Brief Title
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
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic Mellitus, Retinal Disease
Keywords
diabetic macular edema, Macugen, sham-controlled study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pegaptanib sodium
Arm Type
Experimental
Arm Title
sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium
Intervention Description
Intravitreal injection of 0.3 mg every 6 weeks
Intervention Type
Other
Intervention Name(s)
sham injection
Intervention Description
sham injection every 6 weeks
Primary Outcome Measure Information:
Title
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
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Visual Acuity (VA): Double Masked Phase
Description
Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts
Time Frame
Baseline, Weeks 6, 12, 18, and 24
Title
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
Description
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Time Frame
Up to 24 weeks
Title
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
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline and Week 54
Title
Change From Baseline in Visual Acuity (VA): Open Phase
Description
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.
Time Frame
Baseline, Weeks 30, 36, 42, 48 and 54
Title
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase
Description
Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.
Time Frame
Weeks 24 to 54
Other Pre-specified Outcome Measures:
Title
Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Weeks 6, 12, 18, and 24
Title
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase
Description
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.
Time Frame
Baseline, Weeks 6, 12, 18, and 24
Title
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
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Weeks 6, 12, 18, and 24
Title
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
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline and Week 24
Title
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
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase
Description
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.
Time Frame
Baseline and Week 24
Title
Mean Visual Acuity Over Time at Each Time Point: Open Phase
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Weeks 30, 36, 42, 48, and 54
Title
Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase
Description
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.
Time Frame
Baseline, Weeks 30, 36, 42, 48, and 54
Title
Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline, Weeks 30, 36, 42, 48, and 54
Title
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
Description
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time Frame
Baseline and Week 54
Title
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
Description
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.
Time Frame
Baseline and Week 54
Title
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
Description
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.
Time Frame
Baseline and Week 54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Juntendo University Hospital Urayasu, Ophthalmology
City
Urayasu-shi
State/Province
Chiba-Ken
Country
Japan
Facility Name
St. Mary's Hospital
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gumma
Country
Japan
Facility Name
Kimura Eye & Internal Medicine Hospital
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
Asahikawa Medical College Hospital
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Yoshida Eye Hospital
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Kohnan Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaraki
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Kagawa University Hospital
City
Kida-gun
State/Province
Kagawa
Country
Japan
Facility Name
NTT East Tohoku Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Kinki University Hospital, Anesthesiology
City
Osaka-sayama-shi
State/Province
Osaka
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
State/Province
Shiga
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Nihon University Surugadai Hospital
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Ochanomizu Inoue Eye Clinic
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Hirota Eye Clinic
City
Shunan
State/Province
Yamaguchi
Country
Japan
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Facility Name
Aomori Prefectural Chuo Hospital
City
Aomori
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
Country
Japan
Facility Name
Hayashi Eye Hospital
City
Fukuoka
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Murakami Karindo Hospital
City
Fukuoka
Country
Japan
Facility Name
Ohshima Hospital of Ophthalmology
City
Fukuoka
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
Country
Japan
Facility Name
Ideta eye hospital
City
Kumamoto
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
Country
Japan
Facility Name
Osaka general medical center
City
Osaka
Country
Japan
Facility Name
Osaka Saiseikai Izou Hospital
City
Osaka
Country
Japan
Facility Name
Saga Prefectural Hospital Koseikan
City
Saga
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751034&StudyName=A%20Phase%203%20Study%20To%20Compare%20The%20Efficacy%20And%20Safety%20Of%200.3%20MG%20Pegaptanib%20Sodium%20To%20Sham%20Injections%20In%20Subjects%20With%20Diabetic%20Macula
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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