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

Conditions: Macular Edema
Diabetic Mellitus
Retinal Disease

Interventions: Other: sham injection
Drug: pegaptanib sodium

Registration Number: NCT01100307

Lead Sponsor: 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 243

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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.

Trial Locations

Locations (43): Kohnan Hospital
🇯🇵
Kobe, Hyogo, Japan
Nihon University Surugadai Hospital
🇯🇵
Chiyoda-ku, Tokyo, Japan
Shiga University of Medical Science Hospital
🇯🇵
Otsu, Shiga, Japan
Kyushu University Hospital
🇯🇵
Fukuoka, Japan
National Hospital Organization Nagoya Medical Center
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Nagoya, Aichi, Japan
Yoshida Eye Hospital
🇯🇵
Hakodate, Hokkaido, Japan
Kimura Eye & Internal Medicine Hospital
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Kure, Hiroshima, Japan
Hitachi General Hospital
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Hitachi, Ibaraki, Japan
Kagawa University Hospital
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Kida-gun, Kagawa, Japan
Keio University Hospital
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Shinjuku-ku, Tokyo, Japan
Aomori Prefectural Chuo Hospital
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Aomori, Japan
Fukushima Medical University Hospital
🇯🇵
Fukushima, Japan
Ohshima Hospital of Ophthalmology
🇯🇵
Fukuoka, Japan
Kagoshima University Hospital
🇯🇵
Kagoshima, Japan
Kyoto University Hospital
🇯🇵
Kyoto, Japan
Osaka general medical center
🇯🇵
Osaka, Japan
Saga Prefectural Hospital Koseikan
🇯🇵
Saga, Japan
Nagoya City University Hospital
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Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵
Nagoya, Aichi, Japan
Gunma University Hospital
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Maebashi, Gumma, Japan
Mito Kyodo General Hospital
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Mito, Ibaraki, Japan
Hokkaido University Hospital
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Sapporo, Hokkaido, Japan
NTT East Tohoku Hospital
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Sendai, Miyagi, Japan
Kinki University Hospital, Anesthesiology
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Osaka-sayama-shi, Osaka, Japan
Seirei Hamamatsu General Hospital
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Hamamatsu, Shizuoka, Japan
Juntendo University Hospital Urayasu, Ophthalmology
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Urayasu-shi, Chiba-Ken, Japan
Asahikawa Medical College Hospital
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Asahikawa, Hokkaido, Japan
Hyogo Prefectural Amagasaki Hospital
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Amagasaki, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵
Kobe, Hyogo, Japan
Niigata University Medical and Dental Hospital
🇯🇵
Niigata, Japan
St. Mary's Hospital
🇯🇵
Kurume, Fukuoka, Japan
Ochanomizu Inoue Eye Clinic
🇯🇵
Chiyoda-ku, Tokyo, Japan
Shinshu University Hospital
🇯🇵
Matsumoto, Nagano, Japan
Hirota Eye Clinic
🇯🇵
Shunan, Yamaguchi, Japan
Murakami Karindo Hospital
🇯🇵
Fukuoka, Japan
Ideta eye hospital
🇯🇵
Kumamoto, Japan
Osaka Saiseikai Izou Hospital
🇯🇵
Osaka, Japan
Nara Medical University Hospital
🇯🇵
Kashihara, Nara, Japan
Akita University Hospital
🇯🇵
Akita, Japan
Chiba University Hospital
🇯🇵
Chiba, Japan
Hayashi Eye Hospital
🇯🇵
Fukuoka, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵
Meguro-ku, Tokyo, Japan
Osaka City University Hospital
🇯🇵
Osaka, Japan