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

Neovascular Age-related Macular Degeneration Clinical Trial

— MACURELI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549055
• Other study ID #: A5751026
• Status: Completed
• Start date: November 2007
• Est. completion date: October 2009

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients participating in another clinical study with Macugen.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Aarschot
Belgium	Pfizer Investigational Site	Deurne
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Change in VA: Improvement	Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.	Months 3, 6, 9 and 12
Secondary	Number of Participants With Change in VA: Stabilization	Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.	Months 3, 6, 9 and 12
Secondary	Number of Participants With Change in VA: Worsening	Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.	Months 3, 6, 9 and 12
Secondary	Duration of Treatment	Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).	Baseline up to 28.4 months
Secondary	Frequency of Macugen Administration	Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.	Baseline up to 28.4 months
Secondary	Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments	Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).	Months 3, 6, 9 and 12

External Links

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