An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD

NCT00327470 | Terminated Phase 4 Results

• 1 other identifier: A5751017
• Study Type: interventional
• Target: 288
• Locations: 15 countries
• Sites: 58

Brief Summary

The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

Conditions

Age Related Macular Degeneration (AMD); Macular Degeneration; Choroidal Neovascularization (CNV)

Keywords

neovascular age related macular degeneration; choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions

  The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing \>=30 letters or \<15 letters from Baseline, gaining \>=0 or \>=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.

  Baseline through Week 54

Secondary Outcomes (6)

• Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions

  Baseline through Week 102, Week 54 through Week 102

• Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions

  Baseline through Week 54, Baseline through Week 102

• Mean Change in Reading Speed

  Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

• Mean Change From Baseline in Contrast Sensitivity

  Baseline through Week 54, Baseline through Week 102

• Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score

  Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Study Arms (1)

Open Label

EXPERIMENTAL

Drug: Pegaptanib Sodium 0.3 mg

Interventions

Pegaptanib Sodium 0.3 mg DRUG

Pegaptanib Sodium dosed every 6 weeks in affected eye.

Open Label

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
• Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye

You may not qualify if:

• Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
• Subjects having subfoveal fibrosis/ scar or atrophy representing \> 25% of the total lesion size

Sponsors & Collaborators

• Pfizer: lead

Study Sites (58)

Pfizer Investigational Site

Graz, A-8036, Austria

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Pfizer Investigational Site

Innsbruck, A-6020, Austria

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Pfizer Investigational Site

Vienna, A-1030, Austria

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Vienna, A-1180, Austria

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Brussels, 1020, Belgium

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Brussels, 1070, Belgium

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Liège, 4000, Belgium

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Victoria, British Columbia, V8R 1J8, Canada

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Victoria, British Columbia, V8V 4X3, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 4G5, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Pfizer Investigational Site

Olomouc, 775 20, Czechia

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Prague, 128 08, Czechia

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Prague, 140 00, Czechia

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Prague, 169 02, Czechia

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Glostrup Municipality, 2600, Denmark

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Kuopio, Finlad, 70211, Finland

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Marseille, 13008, France

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Nancy, 54035, France

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Nantes, 44093, France

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Paris, 75015, France

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Paris, 75571, France

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Saint-Etienne, 42055, France

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Tours, 37044, France

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Dortmund, 44137, Germany

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Freiburg im Breisgau, 79106, Germany

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Halle, 06120, Germany

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Münster, 48145, Germany

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Athens, 115 27, Greece

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Athens, 155 62, Greece

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Ancona, 60020, Italy

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Bari, 70124, Italy

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Florence, 50134, Italy

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Milan, 20132, Italy

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Milan, 20157, Italy

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Gdansk, 80-952, Poland

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Katowice, 40-952, Poland

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Poznan, 61-848, Poland

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Pfizer Investigational Site

Warsaw, 03-709, Poland

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Pfizer Investigational Site

Coimbra, 3000, Portugal

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Pfizer Investigational Site

Lisbon, 1169-019, Portugal

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Pfizer Investigational Site

Lisbon, 1169-0940, Portugal

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Porto, 4200, Portugal

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Pfizer Investigational Site

Alicante, Alicante, 03016, Spain

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Barcelona, Barcelona, 08025, Spain

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Santiago de Compostela, La Coruña, 15705, Spain

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Valencia, Valencia, 46014, Spain

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Pfizer Investigational Site

Ankara, 06100, Turkey (Türkiye)

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Pfizer Investigational Site

Istanbul, 34098, Turkey (Türkiye)

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Pfizer Investigational Site

Istanbul, 34390, Turkey (Türkiye)

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Pfizer Investigational Site

Edinburgh, Midlothian, EH3 9NA, United Kingdom

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Aberdeen, Scotland, AB25 2ZN, United Kingdom

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Pfizer Investigational Site

Belfast, BT12 6BA, United Kingdom

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Pfizer Investigational Site

Bristol, BS1 2LX, United Kingdom

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Pfizer Investigational Site

Leeds, LS9 7TF, United Kingdom

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Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. doi: 10.1136/bjophthalmol-2011-301444. Epub 2012 Aug 7. No abstract available.

  PMID: 22872673 DERIVED

Related Links

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

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 4, 2012
• Results First Posted: December 17, 2010

Record last verified: 2011-01

Locations

DK (1); CZ (4); CA (6); AU (4); BE (3); PT (4); ES (4); GR (2); IT (5); DE (4); PL (4); FI (1); FR (7); GB (6); TU (3)