Clinical trial NCT00735943: Macugen Observational Study
Official title: Macugen Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vascular Endothelial Growth Factor
Macular Degeneration
Keywords: Pegaptanib
macular degeneration
vascular endothelial growth factor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

Brief summary: The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year

Detailed description: To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.

If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.

The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria: Inclusion Criteria:

* To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

Exclusion Criteria:

* Active or suspected ocular or periocular infection.
* Known hypersensitivity to pegaptanib sodium or any other excipient in this product.

Primary outcomes:
measure: Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)
timeFrame: Baseline through 12 months or last follow-up visit before study termination
measure: Average Number of Injections to Achieve Stabilization of VA
timeFrame: 12 months or last follow-up visit before study termination
measure: Median Number of Injections to Achieve Stabilization of VA
timeFrame: 12 months or last follow-up visit before study termination
Secondary outcomes:
measure: Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA
timeFrame: 12 months or last follow-up visit before study termination
measure: Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
timeFrame: 12 months or last follow-up visit before study termination
measure: Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy
timeFrame: 12 months or last follow-up visit before study termination
measure: Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive
timeFrame: 12 months or last follow-up visit before study termination
Other outcomes:
Locations:
city: Navrangpura, Ahemdabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Gurgaon
country: India
facility: Pfizer Investigational Site
state: Haryana
city: Cochin
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: