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

NCT01100307 | Completed Phase 3 Results

• 1 other identifier: A5751034
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 43

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.

Conditions

Macular Edema; Diabetic Mellitus; Retinal Disease

Keywords

diabetic macular edema; Macugen; sham-controlled study

Outcome Measures

Primary Outcomes (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

  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

Secondary Outcomes (5)

• Change From Baseline in Visual Acuity (VA): Double Masked Phase

  Baseline, Weeks 6, 12, 18, and 24

• Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase

  Up to 24 weeks

• 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

• Change From Baseline in Visual Acuity (VA): Open Phase

  Baseline, Weeks 30, 36, 42, 48 and 54

• Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase

  Weeks 24 to 54

Other Outcomes (12)

• Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase

  Baseline, Weeks 6, 12, 18, and 24

• Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase

  Baseline, Weeks 6, 12, 18, and 24

• 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

  Baseline, Weeks 6, 12, 18, and 24

Study Arms (2)

pegaptanib sodium

EXPERIMENTAL

Drug: pegaptanib sodium

sham injection

SHAM COMPARATOR

Other: sham injection

Interventions

pegaptanib sodium DRUG

Intravitreal injection of 0.3 mg every 6 weeks

pegaptanib sodium

sham injection OTHER

sham injection every 6 weeks

sham injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (43)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Location

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Location

Akita University Hospital

Akita, Akita, Japan

Location

Aomori Prefectural Chuo Hospital

Aomori, Aomori, Japan

Location

Chiba University Hospital

Chiba, Chiba, Japan

Location

Juntendo University Hospital Urayasu, Ophthalmology

Urayasu-shi, Chiba, Japan

Location

Hayashi Eye Hospital

Fukuoka, Fukuoka, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

Murakami Karindo Hospital

Fukuoka, Fukuoka, Japan

Location

Ohshima Hospital of Ophthalmology

Fukuoka, Fukuoka, Japan

Location

St. Mary's Hospital

Kurume, Fukuoka, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Location

Gunma University Hospital

Maebashi, Gunma, Japan

Location

Kimura Eye & Internal Medicine Hospital

Kure, Hiroshima, Japan

Location

Asahikawa Medical College Hospital

Asahikawa, Hokkaido, Japan

Location

Yoshida Eye Hospital

Hakodate, Hokkaido, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Hyogo Prefectural Amagasaki Hospital

Amagasaki, Hyōgo, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Location

Kohnan Hospital

Kobe, Hyōgo, Japan

Location

Hitachi General Hospital

Hitachi, Ibaraki, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Location

Kagawa University Hospital

Kida-gun, Kagawa-ken, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Ideta eye hospital

Kumamoto, Kumamoto, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, Japan

Location

NTT East Tohoku Hospital

Sendai, Miyagi, Japan

Location

Shinshu University Hospital

Matsumoto, Nagano, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Location

Osaka City University Hospital

Osaka, Osaka, Japan

Location

Osaka general medical center

Osaka, Osaka, Japan

Location

Osaka Saiseikai Izou Hospital

Osaka, Osaka, Japan

Location

Kinki University Hospital, Anesthesiology

Osaka-sayama-shi, Osaka, Japan

Location

Saga Prefectural Hospital Koseikan

Saga, Saga-ken, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Location

Nihon University Surugadai Hospital

Chiyoda-ku, Tokyo, Japan

Location

Ochanomizu Inoue Eye Clinic

Chiyoda-ku, Tokyo, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Hirota Eye Clinic

Shūnan, Yamaguchi, Japan

Location

Related Links

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

MeSH Terms

Conditions

Macular Edema; Retinal Diseases

Interventions

pegaptanib; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Eye Diseases

Limitations and Caveats

During the study, an issue was reported concerning proper maintenance of treatment masking. Due to this masking process issue, the study results cannot be interpreted as that arising from a well-controlled double-masked trial.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 8, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 23, 2013
• Results First Posted: July 15, 2013

Record last verified: 2013-05

Locations

JP (43)