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

Macular Degeneration Clinical Trial

— PERSPECTIVES  

Official title:

A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00327470
• Other study ID #: A5751017
• Status: Terminated
• Phase: Phase 4
• First received: May 17, 2006
• Last updated: April 2, 2012
• Start date: July 2006
• Est. completion date: August 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey:Ministry of Health Central Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 288
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration (AMD)
• Choroidal Neovascularization
• Choroidal Neovascularization (CNV)
• Macular Degeneration
• Neovascularization, Pathologic
• Wet Macular Degeneration

Intervention

Drug:
• Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Graz
Austria	Pfizer Investigational Site	Innsbruck
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Liege
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Canada	Pfizer Investigational Site	Victoria	British Columbia
Czech Republic	Pfizer Investigational Site	Olomouc
Czech Republic	Pfizer Investigational Site	Praha 2
Czech Republic	Pfizer Investigational Site	Praha 4
Czech Republic	Pfizer Investigational Site	Praha 6
Denmark	Pfizer Investigational Site	Glostrup
Finland	Pfizer Investigational Site	Kuopio	Finlad
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Nancy Cedex
France	Pfizer Investigational Site	Nantes Cedex 1
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 12
France	Pfizer Investigational Site	St. Etienne Cedex 2
France	Pfizer Investigational Site	Tours cedex 1
Germany	Pfizer Investigational Site	Dortmund
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Halle
Germany	Pfizer Investigational Site	Muenster
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Italy	Pfizer Investigational Site	Ancona
Italy	Pfizer Investigational Site	Bari
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Katowice
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Porto
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Santiago de Compostela	La Coruña
Spain	Pfizer Investigational Site	Valencia
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Istanbul
United Kingdom	Pfizer Investigational Site	Aberdeen	Scotland
United Kingdom	Pfizer Investigational Site	Belfast
United Kingdom	Pfizer Investigational Site	Bristol
United Kingdom	Pfizer Investigational Site	Edinburgh	Midlothian
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Poland,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Change From Baseline in Distance 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 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, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.	Baseline through Week 102, Week 54 through Week 102	No
Secondary	Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions	Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.	Baseline through Week 54, Baseline through Week 102	No
Secondary	Mean Change in Reading Speed	For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102	No
Secondary	Mean Change From Baseline in Contrast Sensitivity	Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.	Baseline through Week 54, Baseline through Week 102	No
Secondary	Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score	Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102	No
Secondary	Mean Change in Euro QoL Questionnaire (EQ-5D) Score	The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems"). A subject's responses to these domains were mapped to a corresponding score of the EQ-5D index.	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102	No

External Links

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