Clinical trial NCT01100307: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Diabetic Mellitus
Retinal Disease
Keywords: diabetic macular edema
Macugen
sham-controlled study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 243
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in Visual Acuity (VA): Double Masked Phase
timeFrame: Baseline, Weeks 6, 12, 18, and 24
measure: Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase
timeFrame: Up to 24 weeks
measure: 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
timeFrame: Baseline and Week 54
measure: Change From Baseline in Visual Acuity (VA): Open Phase
timeFrame: Baseline, Weeks 30, 36, 42, 48 and 54
measure: Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase
timeFrame: Weeks 24 to 54
Other outcomes:
measure: Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase
timeFrame: Baseline, Weeks 6, 12, 18, and 24
measure: Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase
timeFrame: Baseline, Weeks 6, 12, 18, and 24
measure: 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
timeFrame: Baseline, Weeks 6, 12, 18, and 24
measure: 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
timeFrame: Baseline and Week 24
measure: 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
timeFrame: Baseline and Week 24
measure: Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase
timeFrame: Baseline and Week 24
measure: Mean Visual Acuity Over Time at Each Time Point: Open Phase
timeFrame: Baseline, Weeks 30, 36, 42, 48, and 54
measure: Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase
timeFrame: Baseline, Weeks 30, 36, 42, 48, and 54
measure: Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase
timeFrame: Baseline, Weeks 30, 36, 42, 48, and 54
measure: 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
timeFrame: Baseline and Week 54
measure: 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
timeFrame: Baseline and Week 54
measure: 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
timeFrame: Baseline and Week 54
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Urayasu-shi
country: Japan
facility: Juntendo University Hospital Urayasu, Ophthalmology
state: Chiba-Ken
city: Kurume
country: Japan
facility: St. Mary's Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gumma
city: Kure
country: Japan
facility: Kimura Eye & Internal Medicine Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical College Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Yoshida Eye Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kohnan Hospital
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Kida-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Sendai
country: Japan
facility: NTT East Tohoku Hospital
state: Miyagi
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osaka-sayama-shi
country: Japan
facility: Kinki University Hospital, Anesthesiology
state: Osaka
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Chiyoda-ku
country: Japan
facility: Nihon University Surugadai Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Ochanomizu Inoue Eye Clinic
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shunan
country: Japan
facility: Hirota Eye Clinic
state: Yamaguchi
city: Akita
country: Japan
facility: Akita University Hospital
city: Aomori
country: Japan
facility: Aomori Prefectural Chuo Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Murakami Karindo Hospital
city: Fukuoka
country: Japan
facility: Ohshima Hospital of Ophthalmology
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: Ideta eye hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Osaka general medical center
city: Osaka
country: Japan
facility: Osaka Saiseikai Izou Hospital
city: Saga
country: Japan
facility: Saga Prefectural Hospital Koseikan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: