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Trial record 1 of 1 for:    NCT00858208
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Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice. (MACULA)

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ClinicalTrials.gov Identifier: NCT00858208
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 26, 2009
First Posted Date March 9, 2009
Results First Submitted Date March 14, 2012
Results First Posted Date April 11, 2012
Last Update Posted Date April 11, 2012
Study Start Date March 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2012)
Change From Baseline Visual Acuity (VA) at the Final Visit [ Time Frame: Baseline, Week 102 or Early Termination (ET) ]
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Original Primary Outcome Measures
 (submitted: March 6, 2009)
  • The effect of Macugen(pegaptanib sodium) treatment on patient Visual Acuity [ Time Frame: 2 years ]
  • Safety profile of Macugen(pegaptanib sodium) [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: March 14, 2012)
  • Change From Baseline VA at Each Visit [ Time Frame: Baseline, every 6 weeks up to Week 102 ]
    VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
  • Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED) [ Time Frame: Baseline, Week 102 or ET ]
    VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
  • Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit [ Time Frame: Baseline, Month 6, 12, 18, and 24 ]
    Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
  • Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit [ Time Frame: Baseline, Week 102 or ET ]
    Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
  • Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit [ Time Frame: Baseline, Week 102 or ET ]
    Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Original Secondary Outcome Measures
 (submitted: March 6, 2009)
  • Procedures used for AMD diagnosis [ Time Frame: 2 years ]
  • Procedures for monitoring the course of treatment [ Time Frame: 2 years ]
  • Treatment efficacy in patients with REPD [ Time Frame: 2 years ]
  • Patient population that benefit more from treatment with Macugen(pegaptanib sodium) [ Time Frame: 2 years ]
  • Persistency and compliance with Macugen(pegaptanib sodium) [ Time Frame: 2 years ]
  • Effect of Macugen(pegaptanib sodium) in patient quality of life [ Time Frame: 2 years ]
  • Effect of Macugen(pegaptanib sodium) on Intraocular pressure [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures
 (submitted: March 14, 2012)
  • Change From Baseline VA at Final Visit by Age Group [ Time Frame: Baseline, Week 102 or ET ]
    Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
  • Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage [ Time Frame: Baseline, Week 102 or ET ]
    Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
  • Change From Baseline VA at the Final Visit by Previous Treatment of AMD [ Time Frame: Baseline, Week 102 or ET ]
    Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
  • Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment [ Time Frame: Every 6 weeks up to Week 102 ]
    Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
  • Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment [ Time Frame: Every 6 weeks up to Week 102 ]
    Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
  • Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment [ Time Frame: Every 6 weeks up to Week 102 ]
    Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
  • Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study [ Time Frame: Baseline through Week 102 ]
    Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
  • Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection) [ Time Frame: Baseline and Week 102 or ET ]
    IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Official Title Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
Brief Summary Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Detailed Description Eligible patients in routine clinical practice
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Age-related Macula degeneration
Condition Neovascular Age-related Macular Degeneration
Intervention Drug: pegaptanib sodium
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Study Groups/Cohorts Patients with neovascular Age-Related Macula Degeneration
Intervention: Drug: pegaptanib sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 12, 2011)
86
Original Estimated Enrollment
 (submitted: March 6, 2009)
100
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT00858208
Other Study ID Numbers A5751028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2011