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
  Purpose

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.


Condition Intervention Phase
Macular Edema
Diabetic Mellitus
Retinal Disease
Drug: pegaptanib sodium
Other: sham injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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 [ 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.



Enrollment: 243
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pegaptanib sodium Drug: pegaptanib sodium
Intravitreal injection of 0.3 mg every 6 weeks
Sham Comparator: sham injection Other: sham injection
sham injection every 6 weeks

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100307

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01100307     History of Changes
Other Study ID Numbers: A5751034
Study First Received: April 7, 2010
Results First Received: May 15, 2013
Last Updated: August 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
diabetic macular edema
Macugen
sham-controlled study

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014