A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.

NCT00549055 | Completed Results

• 1 other identifier: A5751026
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 4

Brief Summary

To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Macugen Age-related macular degeneration (AMD) Observational study

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Final Visit in Visual Acuity (VA) Score

  Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.

  Baseline, Month 24 or Early Termination

Secondary Outcomes (6)

• Number of Participants With Change in VA: Improvement

  Months 3, 6, 9 and 12

• Number of Participants With Change in VA: Stabilization

  Months 3, 6, 9 and 12

• Number of Participants With Change in VA: Worsening

  Months 3, 6, 9 and 12

• Duration of Treatment

  Baseline up to 28.4 months

• Frequency of Macugen Administration

  Baseline up to 28.4 months

Study Arms (1)

1

Patients who obtained reimbursement of Macugen.

Drug: Macugen

Interventions

Macugen DRUG

Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)

Also known as: Pegaptanib sodium

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.

You may qualify if:

• Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
• Patients having received at least 1 Macugen injection
• Treatment naive patients, or patients having received conventional therapy
• Patients having signed and dated informed consent.

You may not qualify if:

• Patients participating in another clinical study with Macugen.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Aarschot, 3200, Belgium

Location

Pfizer Investigational Site

Deurne, 2100, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Liège, 4000, Belgium

Location

Related Links

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

MeSH Terms

Interventions

pegaptanib

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: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 6, 2018
• Results First Posted: October 27, 2010

Record last verified: 2018-11

Locations

BE (4)