Macugen Observational Study

NCT00735943 | Terminated Results

• 1 other identifier: A5751031
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 5

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

Conditions

Vascular Endothelial Growth Factor; Macular Degeneration

Keywords

Pegaptanib; macular degeneration; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)

  VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.

  Baseline through 12 months or last follow-up visit before study termination

• Average Number of Injections to Achieve Stabilization of VA

  Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.

  12 months or last follow-up visit before study termination

• Median Number of Injections to Achieve Stabilization of VA

  Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.

  12 months or last follow-up visit before study termination

Secondary Outcomes (11)

• Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy

  12 months or last follow-up visit before study termination

• Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters

  12 months or last follow-up visit before study termination

• Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters

  12 months or last follow-up visit before study termination

• Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA

  12 months or last follow-up visit before study termination

• Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions

  12 months or last follow-up visit before study termination

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Pfizer Investigational Site

Navrangpura, Ahemdabad, Gujarat, 380009, India

Location

Pfizer Investigational Site

Gurgaon, Haryana, 122 002, India

Location

Pfizer Investigational Site

Kochi, Kerala, 682 015, India

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 054, India

Location

Pfizer Investigational Site

Jaipur, Rajasthan, 302 004, India

Location

Related Links

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

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

Outcome measures were not designated as primary or secondary measures as this study was an observational non-interventional study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 29, 2011
• Results First Posted: August 16, 2011

Record last verified: 2011-08

Locations

IN (5)