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Completed

NCT Number: NCT00858208

Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Pátrai, Pellopoese, Greece

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About this study

Eligible patients in routine clinical practice

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adults with neovascular age-related macula degeneration

Exclusion criteria

according to SmPC

Treatment and study plan

pegaptanib sodium

Drug

pegaptanib sodium intravitreal injection every 6 weeks for 2 years

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Acronym: MACULA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2009
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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