Macugen Observational Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00735943
• Date of registration: 14/08/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Macugen Observational Study
• Scientific title: Macugen Observational Study
• Date of first enrolment: November 2008
• Target sample size: 22
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00735943
• Study type: Observational
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Vascular Endothelial Growth Factor

Macular Degeneration

Intervention(s)

Other: No intervention

Primary Outcome(s)

Average Number of Injections to Achieve Stabilization of VA [Time Frame: 12 months or last follow-up visit before study termination]

Median Number of Injections to Achieve Stabilization of VA [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA) [Time Frame: Baseline through 12 months or last follow-up visit before study termination]

Secondary Outcome(s)

Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen [Time Frame: 12 months or last follow-up visit before study termination]

Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive [Time Frame: 12 months or last follow-up visit before study termination]

Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters [Time Frame: 12 months or last follow-up visit before study termination]

Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions [Time Frame: 12 months or last follow-up visit before study termination]

Secondary ID(s)

A5751031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00735943