A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

NCT00605280 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: A5751013EOP1013H
• Study Type: interventional
• Target: 317
• Locations: 17 countries
• Sites: 71

Brief Summary

The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.

Conditions

Macular Edema Associated With Diabetes Mellitus

Keywords

randomized sham-controlled multicenter macular edema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year

  Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts

  Baseline, Year 1

Secondary Outcomes (11)

• Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years

  Baseline, Year 2

• Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year

  Baseline, Year 1

• Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years

  Baseline, Year 2

• Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year

  Baseline, Year 1

• Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year

  Baseline, Year 1

Study Arms (2)

Sham Control

SHAM COMPARATOR

Drug: Standard of Care

Macugen

EXPERIMENTAL

Drug: Macugen

Interventions

Standard of Care DRUG

Clinicians decision to use optional laser therapy.

Sham Control

Macugen DRUG

Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.

Macugen

Eligibility Criteria

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

You may qualify if:

• macular edema associated with diabetes
• visual acuity between 20/50 and 20/200

You may not qualify if:

• recent laser therapy in the eye
• recent signs of uncontrolled diabetes
• blood pressure worse than 160/100
• severe cardiac disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (73)

Pfizer Investigational Site

Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85704, United States

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Los Angeles, California, 90095, United States

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Oakland, California, 94609, United States

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Santa Ana, California, 92705, United States

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Denver, Colorado, 80230, United States

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Hamden, Connecticut, 06518, United States

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Fort Lauderdale, Florida, 33334-4146, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33612, United States

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Augusta, Georgia, 30909, United States

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‘Aiea, Hawaii, 96701, United States

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Indianapolis, Indiana, 46280, United States

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Wichita, Kansas, 67214, United States

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Boston, Massachusetts, 02114, United States

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Detroit, Michigan, 48201-1423, United States

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Lynbrook, New York, 11563, United States

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New York, New York, 10021, United States

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Charlotte, North Carolina, 28210, United States

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Pittsburgh, Pennsylvania, 15213, United States

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West Columbia, South Carolina, 29169, United States

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Abilene, Texas, 79606, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77002, United States

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McAllen, Texas, 78503, United States

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San Antonio, Texas, 78240, United States

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Temple, Texas, 76508, United States

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Milwaukee, Wisconsin, 53226, United States

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Westmead, New South Wales, 2145, Australia

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East Melbourne, Australia

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Innsbruck, A-6020, Austria

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Vienna, A-1180, Austria

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Gioania, Goiás, 74210-010, Brazil

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Porto Alegre, 90035-003, Brazil

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São Paulo, 04524-020, Brazil

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São Paulo, SP 04524-20, Brazil

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Vancouver, British Columbia, V5Z 3N9, Canada

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Montreal, Quebec, H1T 2H1, Canada

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Bogotá, Colombia

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Brno, 625 00, Czechia

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Hradec Králové, 50005, Czechia

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Olomouc, 775 20, Czechia

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Prague, 140 00, Czechia

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Prague, 169 00, Czechia

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Glostrup Municipality, 2600, Denmark

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Créteil, Cedex, 94010, France

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Clermont, 63003, France

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Lyon, 69006, France

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Marseille, 13008, France

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Marseille, 13385, France

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Marsielle, 13008, France

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Nancy, 54035, France

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Paris, 75571, France

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Bonn, 53105, Germany

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Düsseldorf, 40225, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04103, Germany

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Münster, 48145, Germany

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Tübingen, 72706, Germany

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Athens, 12462, Greece

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Ahmedabad, 380 004, India

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Bangalore, 560 085, India

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Hyderabad, 500 034, India

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New Delhi, 110 029, India

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Florence, 50134, Italy

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Milan, 20132, Italy

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Udine, 33100, Italy

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Nijmegen, 6500, Netherlands

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Coimbra, 3000-354, Portugal

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Bloemfontein, 9301, South Africa

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Bern, CH-3010, Switzerland

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.

  PMID: 21896838 DERIVED

Related Links

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

MeSH Terms

Interventions

Standard of Care; pegaptanib

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: September 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: July 1, 2011
• Last Updated: November 16, 2018
• Results First Posted: March 30, 2011

Record last verified: 2018-10

Locations

PT (1); IT (3); DK (1); CO (1); DE (6); BR (4); CA (2); AU (2); CZ (5); GB (2); US (28); NL (1); GR (1); ZA (1); CH (1); FR (8); IN (4)