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

Phase 3

Completed

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)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
sham injection	sham injection	-
pegaptanib sodium	pegaptanib sodium	-

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Change From Baseline in Visual Acuity (VA): Double Masked Phase	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
Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase	Up to 24 weeks	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	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.
Change From Baseline in Visual Acuity (VA): Open Phase	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.
Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase	Weeks 24 to 54	Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.

Locations (43): Nagoya City University Hospital
🇯🇵
Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵
Nagoya, Aichi, Japan
National Hospital Organization Nagoya Medical Center
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Nagoya, Aichi, Japan
Juntendo University Hospital Urayasu, Ophthalmology
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Urayasu-shi, Chiba-Ken, Japan
St. Mary's Hospital
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Kurume, Fukuoka, Japan
Gunma University Hospital
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Maebashi, Gumma, Japan
Kimura Eye & Internal Medicine Hospital
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Kure, Hiroshima, Japan
Asahikawa Medical College Hospital
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Asahikawa, Hokkaido, Japan
Yoshida Eye Hospital
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Hakodate, Hokkaido, Japan
Hokkaido University Hospital
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Sapporo, Hokkaido, Japan
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Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan