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

Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100307
• Other study ID #: A5751034
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2010
• Last updated: August 16, 2013
• Start date: May 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Mellitus
• Edema
• Macular Edema
• Retinal Disease
• Retinal Diseases

Intervention

Drug:
• pegaptanib sodium
Intravitreal injection of 0.3 mg every 6 weeks

Other:
• sham injection
sham injection every 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 6, 12, 18, and 24	No
Other	Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase	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.	Baseline, Weeks 6, 12, 18, and 24	No
Other	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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 6, 12, 18, and 24	No
Other	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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 24	No
Other	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	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.	Baseline and Week 24	No
Other	Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase	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.	Baseline and Week 24	No
Other	Mean Visual Acuity Over Time at Each Time Point: Open Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 30, 36, 42, 48, and 54	No
Other	Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase	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.	Baseline, Weeks 30, 36, 42, 48, and 54	No
Other	Number of Participants Who Experience a =10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline, Weeks 30, 36, 42, 48, and 54	No
Other	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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 54	No
Other	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	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.	Baseline and Week 54	No
Other	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	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.	Baseline and Week 54	No
Primary	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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 24	No
Secondary	Change From Baseline in Visual Acuity (VA): Double Masked Phase	Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts	Baseline, Weeks 6, 12, 18, and 24	No
Secondary	Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase	Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.	Up to 24 weeks	No
Secondary	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	Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.	Baseline and Week 54	No
Secondary	Change From Baseline in Visual Acuity (VA): Open Phase	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.	Baseline, Weeks 30, 36, 42, 48 and 54	No
Secondary	Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase	Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.	Weeks 24 to 54	No

External Links

•   To obtain contact information for a study center near you, click here.