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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01100307
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : July 15, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100307


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01100307    
Other Study ID Numbers: A5751034
First Posted: April 8, 2010    Key Record Dates
Results First Posted: July 15, 2013
Last Update Posted: August 23, 2013
Last Verified: May 2013
Keywords provided by Pfizer:
diabetic macular edema
Macugen
sham-controlled study
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Edema
Macular Degeneration
Retinal Degeneration
Eye Diseases